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["Basic information",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 1. Randomization process",null,null,null,null,null,null,null,null,null,"Domain 2. Deviations from intended interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 3. Mising outcome data",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 4. Measurement of the outcome",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 5. Selection of the reported result",null,null,null,null,null,null,null,null,null,null,"Domain 6. Overall Bias"]
["Time","Unique ID","Assessor","Study ID","Reference","Experimental","Comparator","Outcome","Results","Aim","Effect of adhering to intervention?","Weight","Sources","1.1","1.2","Note for 1.1&1.2","1.3","Note for 1.3","1.0 Algorithm result","1.0 Assessor's Judgement","1.0 General note","1.0 Optional Question","1.0 Note for optional question","2.1","2.2","Note for 2.1&2.2","2.3","Note for 2.3","2.4","Note for 2.4","2.5","Note for 2.5","2.6","Note for 2.6","2.7","Note for 2.7","2.0 Algorithm result","2.0 Assessor's Judgement","2.0 General Notes","2.0 Optional Question","2.0 Note for optional question","3.1","Note for 3.1","3.2","Note for 3.2","3.3","Note for 3.3&3.4","3.4","Note for 3.4 (not use)","3.0 Algorithm result","3.0 Assessor's judgement","3.0 Gerenal notes","3.0 Optional Question","3.0 Note for optional question","4.1","Note for 4.1","4.2","Note for 4.2","4.3","Note for 4.3","4.4","Note for 4.4&4.5","4.5","Note for 4.5 (not use)","4.0 Algorithm result","4.0 Assessor's Judgement","4.0 General note","4.0 Optional Question","4.0 Note for optional question","5.1","Note for 5.1","5.2","Note for 5.2","5.3","Note for 5.3","5.0 Algorithm result","5.0 Assessor's Judgement","5.0 General note","5.0 Optional Question","5.0 Note for optional question","Algorithm's overall Judgement","Assessor's overall Judgement","6.0 General Note","6.0 Optional Question","6.0 Note for optional question"]
["2021.07.29 17.00","Lundgren_2020_mortality","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Mortality at day 28","RR 1.39 (95% CI: 0.40 to 4.83)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.08.03 12.49","Lundgren (preprint)_2021_mortality_90","NK, CH","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Mortality at day 90","HR 1.09 (95% CI: 0.49 to 2.43)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 12.28","Lundgren_2020_development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","RR 1.17 (95% CI: 0.75 to1.85)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 311 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 311 out of 326 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 13.55","Lundgren_2020_Hospital-discharge_day5","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Hospital discharge at day 5","RR 0.98 (95% CI: 0.81 to 1.19)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 14.20","Lundgren_2020_Hospital-discharge_TTE","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Hospital discharge TTE up to 26 October 2020","HR 0.97 (95% CI: 0.78 to 1.20)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention to treat analysis was performed: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 12.28","Lundgren_2020_development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","RR 1.49 (95% CI: 0.50 to 4.46)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 311 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 311 out of 326 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 14.32","Lundgren_2020_SAE","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","serious adverse events up to day 28","RR 0.93 (95% CI: 0.27 to 3.14)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.08.03 12.57","Lundgren (preprint)_2021_SAE_90","NK, CH","ACTIV-3",null,"Bamlanivimab 7g","Placebo","serious adverse events up to day 90","RR 0.70 (95% CI: 0.29 to 1.67)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned as a \"composite of SAEs, including the protocol-specified exempt events, or death through day 90\" and SAEs were reported separately.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 14.26","Lundgren_2020_AE_3and4","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Grade 3 and 4 adverse events up to day 28","RR 1.27 (95% CI: 0.81 to 1.98)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.08.03 13.08","Lundgren (preprint)_2021_sustained recovery","NK, CH","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Sustained recovery up to day 90","HR 0.99 (95% CI: 0.80 to 1.23)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.35","Lundgren_2020_neurological-dysfunction: transient ischemic events","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: transient ischemic events","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.35","Lundgren_2020_neurological-dysfunction: acute delirium CVA","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: acute delirium CVA","RR 3.71 (95%CI: 0.42 to 32.80)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.36","Lundgren_2020_neurological-dysfunction: cerebrovascular event","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: cerebrovascular event","RR 0.31 (95% CI: 0.01 to 7.53)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.36","Lundgren_2020_thromboembolic events","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Thromboembolic events","RR 2.78 (95% CI: 0.29 to 26.44)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.36","Lundgren_2020_Renal dysfunction (or need for dialysis) at day 28","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Renal dysfunction (or need for dialysis) at day 28","RR 4.64 (95% CI: 0.22 to 95.83)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 14.55","Gottlieb_2020_mortality_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains. "]
["2021.04.30 12.15","Gottlieb_2020_mortality_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 263 out of 270 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 12.17","Gottlieb_2020_mortality_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 09.21","Gottlieb_2020_mortality_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","Mortality at day 28",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","Y","There are no baseline differences that would suggest a problem with randomisation, but the treatment arm was added sequentially and most participants in the placebo group were randomised at a different (earlier) time point. The staggered start of treatment arms, by adjusting for the allocation ratio, caused that from 22. August 2021, participants were mainly included in the bamlanivimab/etesevimab arm (N = 518) and only few (N = 13) into the control arm. Standard of care is evolving quickly and groups may not be comparable.","Some concerns","High","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation, but most participants in the placebo group were randomised at a different time point and groups may not be comparable.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 268 out of 275 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"High","High","For this outcome, there is a low risk of bias due to deviations from the intended intervention, due to missing outcomes, due to the measurement of the outcome and due to selection of reported results. However, there is a high risk of bias due to the randomisation process. "]
["2021.04.30 11.02","Gottlieb_2020_hospital-admission_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","Admission to hospital","RR 0.17 (95% CI: 0.02 to 1.33)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 11.56","Gottlieb_2020_hospital-admission_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","admission to hospital at day 29","RR 0.32 (95% CI: 0.07 to 1.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 263 out of 270 participants randomised.",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 11.57","Gottlieb_2020_hospital-admission_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","admission to hospital at day 29","RR 0.34 (95% CI: 0.08 to 1.56)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 09.26","Gottlieb_2020_hospital-admission_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","admission to hospital at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","Y","There are no baseline differences that would suggest a problem with randomisation, but the treatment arm was added sequentially and most participants in the placebo group were randomised at a different (earlier) time point. The staggered start of treatment arms, by adjusting for the allocation ratio, caused that from 22. August 2021, participants were mainly included in the bamlanivimab/etesevimab arm (N = 518) and only few (N = 13) into the control arm. Standard of care is evolving quickly and groups may not be comparable.","Some concerns","High","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation, but most participants in the placebo group were randomised at a different time point and groups may not be comparable.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 268 out of 275 participants randomised.",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"High","High","For this outcome, there is a low risk of bias due to deviations from the intended intervention, due to missing outcomes, due to the measurement of the outcome and due to selection of reported results. However, there is a high risk of bias due to the randomisation process."]
["2021.05.10 19.02","Gottlieb_2020_viral-clearance7_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","viral clearance at day 7","RR 0.92 (95% CI: 0.43 to 1.93)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 244 out of 265 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 5 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.00","Gottlieb_2020_viral-clearance7_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","viral clearance at day 7","RR 1.08 (95% CI: 0.53 to 2.18)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 246 out of 270 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 8 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 18.57","Gottlieb_2020_viral-clearance7_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","viral clearance at day 7","RR 0.73 (95% CI: 0.33 to 1.65)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 244 out of 265 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 5 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 09.28","Gottlieb_2020_viral-clearance7_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","viral clearance at day 7",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","Y","There are no baseline differences that would suggest a problem with randomisation, but the treatment arm was added sequentially and most participants in the placebo group were randomised at a different (earlier) time point. The staggered start of treatment arms, by adjusting for the allocation ratio, caused that from 22. August 2021, participants were mainly included in the bamlanivimab/etesevimab arm (N = 518) and only few (N = 13) into the control arm. Standard of care is evolving quickly and groups may not be comparable.","Some concerns","High",": Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation, but most participants in the placebo group were randomised at a different time point and groups may not be comparable.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 245 out of 275 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 14 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"High","High","For this outcome, there is a low risk of bias due to deviations from the intended intervention, due to missing outcomes, due to the measurement of the outcome and due to selection of reported results. However, there is a high risk of bias due to the randomisation process."]
["2021.05.10 18.49","Gottlieb_2020_viral-clearance15_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","viral clearance at day 15","RR 1.07 (95% CI: 0.69 to 1.66)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 223 out of 265 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 13 participants in the treatment arm and of 29 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory.","N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 18.52","Gottlieb_2020_viral-clearance15_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","viral clearance at day 15","RR 1.20 (95% CI: 0.79 to 1.82)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 229 out of 270 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 12 participants in the treatment arm and of 29 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory.","N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 18.52","Gottlieb_2020_viral-clearance15_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","viral clearance at day 15","RR 1.03 (95% CI: 0.66 to 1.61)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 226 out of 265 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 10 participants in the treatment arm and of 29 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory.","N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 09.31","Gottlieb_2020_viral-clearance15_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","viral clearance at day 15",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","Y","There are no baseline differences that would suggest a problem with randomisation, but the treatment arm was added sequentially and most participants in the placebo group were randomised at a different (earlier) time point. The staggered start of treatment arms, by adjusting for the allocation ratio, caused that from 22. August 2021, participants were mainly included in the bamlanivimab/etesevimab arm (N = 518) and only few (N = 13) into the control arm. Standard of care is evolving quickly and groups may not be comparable.","Some concerns","High","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation, but most participants in the placebo group were randomised at a different time point and groups may not be comparable.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 230 out of 275 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 16 participants in the treatment arm and of 29 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory.","N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"High","High","For this outcome, there is a low risk of bias due to deviations from the intended intervention, due to missing outcomes, due to the measurement of the outcome and due to selection of reported results. However, there is a high risk of bias due to the randomisation process."]
["2021.04.30 16.48","Gottlieb_2020_AEall_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","adverse events all grades","RR 0.99 (95% CI: 0.66 to 1.50)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 16.48","Gottlieb_2020_AEall_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","adverse events all grades","RR 0.90 (95% CI: 0.59 to 1.38)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 263 out of 270 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 16.48","Gottlieb_2020_AEall_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","adverse events all grades","RR 0.81 (95% CI: 0.52 to 1.27)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 09.32","Gottlieb_2020_AEall_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","adverse events all grades",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","Y","There are no baseline differences that would suggest a problem with randomisation, but the treatment arm was added sequentially and most participants in the placebo group were randomised at a different (earlier) time point. The staggered start of treatment arms, by adjusting for the allocation ratio, caused that from 22. August 2021, participants were mainly included in the bamlanivimab/etesevimab arm (N = 518) and only few (N = 13) into the control arm. Standard of care is evolving quickly and groups may not be comparable.","Some concerns","High","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation, but most participants in the placebo group were randomised at a different time point and groups may not be comparable.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 268 out of 275 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"High","High","For this outcome, there is a low risk of bias due to deviations from the intended intervention, due to missing outcomes, due to the measurement of the outcome and due to selection of reported results. However, there is a high risk of bias due to the randomisation process."]
["2021.05.02 11.46","Gottlieb_2020_SAE_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","serious adverse events (SAEs)","RR 0.51 (95% CI: 0.02 to 12.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 11.46","Gottlieb_2020_SAE_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","serious adverse events (SAEs)","RR 0.48 (95% CI: 0.02 to 11.78)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised and 263 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 263 out of 270 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 11.46","Gottlieb_2020_SAE_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","serious adverse events (SAEs)","RR 0.51 (95% CI: 0.02 to 12.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 09.34","Gottlieb_2020_SAE_Bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","serious adverse events (SAEs)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","Y","There are no baseline differences that would suggest a problem with randomisation, but the treatment arm was added sequentially and most participants in the placebo group were randomised at a different (earlier) time point. The staggered start of treatment arms, by adjusting for the allocation ratio, caused that from 22. August 2021, participants were mainly included in the bamlanivimab/etesevimab arm (N = 518) and only few (N = 13) into the control arm. Standard of care is evolving quickly and groups may not be comparable.","Some concerns","High","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation, but most participants in the placebo group were randomised at a different time point and groups may not be comparable.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised and 268 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 268 out of 275 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"High","High","For this outcome, there is a low risk of bias due to deviations from the intended intervention, due to missing outcomes, due to the measurement of the outcome and due to selection of reported results. However, there is a high risk of bias due to the randomisation process."]
["2021.07.02 15.19","Gupta_2021 (preprint)_mortality","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","Mortality at day 29","RR 0,33 (95% CI: 0,01 to 8,18)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Eligible patients were randomized 1:1 using an interactive web response system\".","N","There are no baseline differences that would suggest a problem with randomisation: \"Treatment groups in the ITT population were well balanced for baseline demographic and disease characteristics.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","This is a double-blinded study. Participants and people delivering the intervention were probably unaware of intervention received: \"Study pharmacists reconstituted and dispensed all study medications within equal time frames to maintain blinding\".","NA",null,"NA",null,"NA",null,"Y","Yes, an intention to treat analysis was performed: \"The interim analysis intent-to-treat (ITT) population included all randomized patients through the prespecified interim analysis cutoff date of January 19, 2021, irrespective of whether they received study drug.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for all participants (583 participants randomised and 583 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 583 out of 583 participants randomised.",null,null,"PN","There was no protocol available, but we assume that mortality was assessed in a standard way.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The trial protocol and SAP were not available, but from the trial registry we could compare the outcomes planned and reported and there were no inconsistencies. ","PN","There is no indication that data was measured in multiple ways. ","NI","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary. However, overall, 1057 participants were randomised up to stopping the trial on March 10, 2021. There were separate data cutoffs for efficacy and safety.","Some concerns","Some concerns","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias from the randomization process, due to deviations from intended interventions, due to missing outcomes and due to measurement of the outcome. However, there are some concerns for bias due to selection of the reported results."]
["2021.07.02 15.20","Gupta_2021 (preprint)_clinical progression day 29: oxy","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","development of severe symptoms according to WHO scale (>=5, incl. death)","RR 0,11 (95% CI: 0,02 to 0,45)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Eligible patients were randomized 1:1 using an interactive web response system\".","N","There are no baseline differences that would suggest a problem with randomisation: \"Treatment groups in the ITT population were well balanced for baseline demographic and disease characteristics.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","This is a double-blinded study. Participants and people delivering the intervention were probably unaware of intervention received: \"Study pharmacists reconstituted and dispensed all study medications within equal time frames to maintain blinding\".","NA",null,"NA",null,"NA",null,"Y","Yes, an intention to treat analysis was performed: \"The interim analysis intent-to-treat (ITT) population included all randomized patients through the prespecified interim analysis cutoff date of January 19, 2021, irrespective of whether they received study drug.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for all participants (583 participants randomised and 583 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 583 out of 583 participants randomised.",null,null,"PN","There was no protocol available, but we assume that the outcome was assessed in a standard way.","N","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The trial protocol and SAP were not available, but from the trial registry we could compare the outcomes planned and reported and there were no inconsistencies. ","PN","There is no indication that data was measured in multiple ways. ","NI","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary. However, overall, 1057 participants were randomised up to stopping the trial on March 10, 2021. There were separate data cutoffs for efficacy and safety.","Some concerns","Some concerns","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias from the randomization process, due to deviations from intended interventions, due to missing outcomes and due to measurement of the outcome. However, there are some concerns for bias due to selection of the reported results."]
["2021.06.25 16.40","Gupta_2021 (preprint)_clinical progression day 29: IMV","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","development of severe symptoms according to WHO scale (>=7, IMV, incl. death)","RR 0,14 (95% CI: 0,01 to 2,76)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Eligible patients were randomized 1:1 using an interactive web response system\".","N","There are no baseline differences that would suggest a problem with randomisation: \"Treatment groups in the ITT population were well balanced for baseline demographic and disease characteristics.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","This is a double-blinded study. Participants and people delivering the intervention were probably unaware of intervention received: \"Study pharmacists reconstituted and dispensed all study medications within equal time frames to maintain blinding\".","NA",null,"NA",null,"NA",null,"Y","Yes, an intention to treat analysis was performed: \"The interim analysis intent-to-treat (ITT) population included all randomized patients through the prespecified interim analysis cutoff date of January 19, 2021, irrespective of whether they received study drug.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for all participants (583 participants randomised and 583 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 583 out of 583 participants randomised.",null,null,"PN","There was no protocol available, but we assume that the outcome was assessed in an appropriate way.","N","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The trial protocol and SAP were not available, but information provided included several stages of oxygen requirement.","PN","There is no indication that data was measured in multiple ways. ","NI","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary. However, overall, 1057 participants were randomised up to stopping the trial on March 10, 2021. There were separate data cutoffs for efficacy and safety.","Some concerns","Some concerns","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias from the randomization process, due to deviations from intended interventions, due to missing outcomes and due to measurement of the outcome. However, there are some concerns for bias due to selection of the reported results."]
["2021.07.02 15.21","Gupta_2021 (preprint)_hospital admission","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","hospitalised or death >= 24 hours for any cause","RR 0,14 (95% CI: 0,04 to 0,48)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Eligible patients were randomized 1:1 using an interactive web response system\".","N","There are no baseline differences that would suggest a problem with randomisation: \"Treatment groups in the ITT population were well balanced for baseline demographic and disease characteristics.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","This is a double-blinded study. Participants and people delivering the intervention were probably unaware of intervention received: \"Study pharmacists reconstituted and dispensed all study medications within equal time frames to maintain blinding\".","NA",null,"NA",null,"NA",null,"Y","Yes, an intention to treat analysis was performed: \"The interim analysis intent-to-treat (ITT) population included all randomized patients through the prespecified interim analysis cutoff date of January 19, 2021, irrespective of whether they received study drug.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for all participants (583 participants randomised and 583 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 583 out of 583 participants randomised.",null,null,"PN","The outcome measurement was not described in the trial, but probably assessed objectively on a case report form.","N","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The trial protocol and SAP were not available, but from the trial registry we could compare the outcomes planned and reported and there were no inconsistencies. ","PN","There is no indication that data was measured in multiple ways. ","NI","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary. However, overall, 1057 participants were randomised up to stopping the trial on March 10, 2021. There were separate data cutoffs for efficacy and safety.","Some concerns","Some concerns","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias from the randomization process, due to deviations from intended interventions, due to missing outcomes and due to measurement of the outcome. However, there are some concerns for bias due to selection of the reported results."]
["2021.06.25 17.18","Gupta_2021 (preprint)_ICU admission","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","admission to ICU for any cause","RR 0,09 (95% CI: 0,01 to 1,64)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Eligible patients were randomized 1:1 using an interactive web response system\".","N","There are no baseline differences that would suggest a problem with randomisation: \"Treatment groups in the ITT population were well balanced for baseline demographic and disease characteristics.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","This is a double-blinded study. Participants and people delivering the intervention were probably unaware of intervention received: \"Study pharmacists reconstituted and dispensed all study medications within equal time frames to maintain blinding\".","NA",null,"NA",null,"NA",null,"Y","Yes, an intention to treat analysis was performed: \"The interim analysis intent-to-treat (ITT) population included all randomized patients through the prespecified interim analysis cutoff date of January 19, 2021, irrespective of whether they received study drug.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for all participants (583 participants randomised and 583 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 583 out of 583 participants randomised.",null,null,"PN","There was no protocol available, but we assume that the outcome was assessed in an appropriate way.","N","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The statistical analysis plan and protocol were not available, but the outcome of each individual patient regarding hospitalisation, IMV and death was provided in the appendix.","PN","There is no indication that data was measured in multiple ways. ","NI","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary. However, overall, 1057 participants were randomised up to stopping the trial on March 10, 2021. There were separate data cutoffs for efficacy and safety.","Some concerns","Some concerns","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias from the randomization process, due to deviations from intended interventions, due to missing outcomes and due to measurement of the outcome. However, there are some concerns for bias due to selection of the reported results."]
["2021.07.02 15.44","Gupta_2021 (preprint)_AEall","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","adverse events any grade","RR 0,87 (95% CI: 0,66 to 1,16)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Eligible patients were randomized 1:1 using an interactive web response system\".","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics in the safety analysis population were similar across treatment groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","This is a double-blinded study. Participants and people delivering the intervention were probably unaware of intervention received: \"Study pharmacists reconstituted and dispensed all study medications within equal time frames to maintain blinding\".","NA",null,"NA",null,"NA",null,"Y","Yes, \"the interim analysis safety analysis population included all patients who received study medication and were randomized through February 17, 2021; patients were grouped according to the actual treatment received.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for all participants (868 participants randomised and 868 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 868 out of 868 participants randomised.",null,null,"PN","There was no protocol available, but we assume that the outcome was assessed in an appropriate way.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The trial protocol and SAP were not available, but from the trial registry we could compare the outcomes planned and there were no inconsistencies. ","NI","Endpoint measured as planned at trial registration stage, but the time point is not entirely clear (probably measured throughout the entire follow-up period instead of day 29).","NI","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary. However, overall, 1057 participants were randomised up to stopping the trial on March 10, 2021. There were separate data cutoffs for efficacy and safety.","Some concerns","Some concerns","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary and the time point measured was not entirely clear.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias from the randomization process, due to deviations from intended interventions, due to missing outcomes and due to measurement of the outcome. However, there are some concerns for bias due to selection of the reported results."]
["2021.07.02 15.44","Gupta_2021 (preprint)_AE grade 3_4","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","adverse events grade 3 and 4","RR 0,26 (95% CI: 0,12 to 0,60)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Eligible patients were randomized 1:1 using an interactive web response system\".","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics in the safety analysis population were similar across treatment groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","This is a double-blinded study. Participants and people delivering the intervention were probably unaware of intervention received: \"Study pharmacists reconstituted and dispensed all study medications within equal time frames to maintain blinding\".","NA",null,"NA",null,"NA",null,"Y","Yes, \"the interim analysis safety analysis population included all patients who received study medication and were randomized through February 17, 2021; patients were grouped according to the actual treatment received.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for all participants (868 participants randomised and 868 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 868 out of 868 participants randomised.",null,null,"PN","There was no protocol available, but we assume that the outcome was assessed in an appropriate way.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The trial protocol and SAP were not available, but from the trial registry we could compare the outcomes planned and there were no inconsistencies. ","NI","Endpoint measured as planned at trial registration stage, but the time point is not entirely clear (probably measured throughout the entire follow-up period instead of day 29).","NI","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary. However, overall, 1057 participants were randomised up to stopping the trial on March 10, 2021. There were separate data cutoffs for efficacy and safety.","Some concerns","Some concerns","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary and the time point measured was not entirely clear.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias from the randomization process, due to deviations from intended interventions, due to missing outcomes and due to measurement of the outcome. However, there are some concerns for bias due to selection of the reported results."]
["2021.07.02 15.38","Gupta_2021 (preprint)_SAE","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","serious adverse events","RR 0,27 (95% CI: 0,12 to 0,63)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Eligible patients were randomized 1:1 using an interactive web response system\".","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics in the safety analysis population were similar across treatment groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","This is a double-blinded study. Participants and people delivering the intervention were probably unaware of intervention received: \"Study pharmacists reconstituted and dispensed all study medications within equal time frames to maintain blinding\".","NA",null,"NA",null,"NA",null,"Y","Yes, \"the interim analysis safety analysis population included all patients who received study medication and were randomized through February 17, 2021; patients were grouped according to the actual treatment received.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for all participants (868 participants randomised and 868 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 868 out of 868 participants randomised.",null,null,"PN","There was no protocol available, but we assume that the outcome was assessed in an appropriate way.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The trial protocol and SAP were not available, but from the trial registry we could compare the outcomes planned and there were no inconsistencies. ","NI","Endpoint measured as planned at trial registration stage, but the time point is not entirely clear (probably measured throughout the entire follow-up period instead of day 29).","NI","There is no indication that data was analysed in multiple ways and one analysis was selected.","Some concerns","Some concerns","The trial protocol and SAP were not available. We have some concerns regarding selection of the reported results because the trial was stopped preliminary and the time point measured was not entirely clear.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias from the randomization process, due to deviations from intended interventions, due to missing outcomes and due to measurement of the outcome. However, there are some concerns for bias due to selection of the reported results."]
["2021.07.07 11.19","Eom_2021 (preprint)_mortality_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.06.27 14.13","Eom_2021 (preprint)_mortality_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","PN","It is unlikely that the number of participants who were excluded from the analysis or analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.49","Eom_2021 (preprint)_clinical progression day 28_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","Clinical progression at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","PN","It is unlikely that the number of participants who were excluded from the analysis or analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.49","Eom_2021 (preprint)_clinical progression day 28_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","Clinical progression at day 28","RR 3,00 (95% CI: 0,12 to 72,80)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","PN","It is unlikely that the number of participants who were excluded from the analysis or analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.48","Eom_2021 (preprint)_hospital admission_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","hospital admission","RR 0,45 (95% CI: 0,14 to 1,42)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","PN","It is unlikely that the number of participants who were excluded from the analysis or analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.48","Eom_2021 (preprint)_hospital admission_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","hospital admission","RR 0,56 (95% CI: 0,19 to 1,60)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","PN","It is unlikely that the number of participants who were excluded from the analysis or analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.48","Eom_2021 (preprint)_ICU admission_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","ICU admission","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","PN","It is unlikely that the number of participants who were excluded from the analysis or analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.47","Eom_2021 (preprint)_ICU admission_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","ICU admission","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","PN","It is unlikely that the number of participants who were excluded from the analysis or analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.46","Eom_2021 (preprint)_viral clearance day14_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","viral clearance day 14","RR 1,12 (95% CI: 0,91 to 1,38)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","PN","It is unlikely that the number of participants who were excluded from the analysis or analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.45","Eom_2021 (preprint)_viral clearance day14_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","viral clearance day 14","RR 1,10 (95% CI: 0,89 to 1,35)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"efficacy was assessed in the intent-to-treat infected (ITTI) population, which comprised all randomly assigned patients with confirmed SARS-CoV-2 infection assessed by pre-infusion RT-qPCR on day 1 and receiving a partial or complete dose of study drug\" and \"there was one major protocol deviation: one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses\", but we assume that this is unlikely to have an impact.","PN","It is unlikely that the number of participants who were excluded from the analysis or analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"PY","Data for this outcome was available for nearly all participants (327 participants randomised and 307 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 307 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.50","Eom_2021 (preprint)_AEall_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","adverse events all grades","RR 0,96 (95% CI: 0,64 to 1,43)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"The safety population included all randomized participants who received a partial or full dose of the study drug\", one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses.\"","PN","It is unlikely that the number of participants who were analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"Y","Data for this outcome was available for nearly all participants (327 participants randomised and 325 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 325 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.50","Eom_2021 (preprint)_AEall_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","adverse events all grades","RR 0,79 (95% CI: 0,52 to 1,22)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"The safety population included all randomized participants who received a partial or full dose of the study drug\", one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses.\"","PN","It is unlikely that the number of participants who were analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"Y","Data for this outcome was available for nearly all participants (327 participants randomised and 325 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 325 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.52","Eom_2021 (preprint)_AE_3 and 4_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","adverse events grade 3 and 4","RR 2,62 (95% CI: 0,52 to 13,21)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","\"The safety population included all randomized participants who received a partial or full dose of the study drug\", one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses.\"","PN","It is unlikely that the number of participants who were analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"Y","Data for this outcome was available for nearly all participants (327 participants randomised and 325 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 325 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.02 13.53","Eom_2021 (preprint)_AE_3 and 4_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","adverse events grade 3 and 4","RR 2,00 (95% CI: 0,37 to 10,70)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"The safety population included all randomized participants who received a partial or full dose of the study drug\", one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses.\"","PN","It is unlikely that the number of participants who were analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"Y","Data for this outcome was available for nearly all participants (327 participants randomised and 325 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 325 out of 327 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.07 11.31","Eom_2021 (preprint)_SAE_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","treatment emergent serious adverse events","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"The safety population included all randomized participants who received a partial or full dose of the study drug\", one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses.\"","PN","It is unlikely that the number of participants who were analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"Y","Data for this outcome was available for nearly all participants (327 participants randomised and 325 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 325 out of 327 participants randomised.",null,null,"N","The outcome was specified at protocol level.","PN","Differences in measurement between groups were unlikey.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The results analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.07 11.12","Eom_2021 (preprint)_SAE_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","treatment emergent serious adverse events","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Randomization was performed using an interactive web response system\r\nand a randomization schedule prepared by unblinded biostatisticians.\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Baseline demographic and disease characteristics were generally well balanced between groups.\"","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Participants, personnel, and outcome assessors were blinded to treatment allocation for the duration of the study.\"","NA",null,"NA",null,"NA",null,"PY","Yes, \"The safety population included all randomized participants who received a partial or full dose of the study drug\", one patient randomized to the placebo group had instead partially received CT-P59; this patient was considered as having received CT-P59 40 mg/kg and was included in the CT-P59 40mg/kg treatment group for the efficacy and safety analyses.\"","PN","It is unlikely that the number of participants who were analysed in the wrong intervention was sufficient that there could have been a substancial impact on the result. ","Low","Low","Both participants and those delivering the intervention were unaware of the intervention received. Participants with a negative PCR were excluded from analysis in both groups (intervention and placebo group) and one participant in the placebo arm did not receive the allocated intervention. The analysis was probably appropriate. ",null,null,"Y","Data for this outcome was available for nearly all participants (327 participants randomised and 325 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 325 out of 327 participants randomised.",null,null,"N","The outcome was specified at protocol level.","PN","Differences in measurement between groups were unlikey.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The results analysed were in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.05 09.26","Weinreich_2021 (preprint)_mortality_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","Mortality at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (1678 participants randomised and 1484 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 1484 out of 1678 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes planned and reported and there were no inconsistencies. ","PN","There is no indication that several measurements have been used to assess mortality.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and probably reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due selection of the reported results. There is a high risk of bias bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 09.29","Weinreich_2021 (preprint)_mortality_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","Mortality at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (3029 participants randomised and 2696 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 2696 out of 3029 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes planned and reported and there were no inconsistencies. ","PN","There is no indication that several measurements have been used to assess mortality.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 09.36","Weinreich_2021 (preprint)_mortality_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","Mortality at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (1360 participants randomised and 1218 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 4057 out of 5607 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes planned and reported and there were no inconsistencies. ","PN","There is no indication that several measurements have been used to assess this outcome.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.20","Weinreich_2021 (preprint)_clinical progression_1.2g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","IMV at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (1678 participants randomised and 1484 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 1484 out of 1678 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes planned and reported and there were no inconsistencies. ","PN","The time point is in accordance with an earlier version of the protocol.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.20","Weinreich_2021 (preprint)_clinical progression_2.4g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","IMV at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (3029 participants randomised and 2696 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 2696 out of 3029 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes planned and reported and there were no inconsistencies. ","PN","The time point is in accordance with an earlier version of the protocol.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.30","Weinreich_2021 (preprint)_hospital admission_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","hospital admission or death at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (1678 participants randomised and 1484 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 1484 out of 1678 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes and there was only hospital admission planned. More outcomes/outcome combinations reported than initially planned. \"post-hoc\" analysis","PN","The time point is in accordance with an earlier version of the protocol.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","Amended phase 3 protocol was not available, but time point is in accordance with earlier version of protocol.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 11.27","Weinreich_2021 (preprint)_hospital admission_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","hospital admission or death at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (3029 participants randomised and 2696 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 2696 out of 3029 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes and there was only hospital admission planned. More outcomes/outcome combinations reported than initially planned. \"post-hoc\" analysis","PN","The time point is in accordance with an earlier version of the protocol.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","Amended phase 3 protocol was not available, but time point is in accordance with earlier version of protocol.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 11.27","Weinreich_2021 (preprint)_hospital admission_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","hospital admission or death at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (1360 participants randomised and 1218 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 1218 out of 1360 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes and there was only hospital admission planned. More outcomes/outcome combinations reported than initially planned. \"post-hoc\" analysis","PN","The time point is in accordance with an earlier version of the protocol.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","Amended phase 3 protocol was not available, but time point is in accordance with earlier version of protocol.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 12.15","Weinreich_2021 (preprint)_length of hospital stay_1.2g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","Length of hospital stay",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Days of hospitalisation were reported for 31 participants, but only 29 participants had been hospitalised.","PN","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 31 out of 29 participants hospitalised. There is no evidence that the result was not biased by missing outcome data. there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes planned and reported and there were no inconsistencies. ","N","The time point is in accordance with an earlier version of the protocol.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","Amended phase 3 protocol was not available, but time point is in accordance with earlier version of protocol.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 12.15","Weinreich_2021 (preprint)_length of hospital stay_2.4g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","Length of hospital stay",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Days of hospitalisation were reported for 80 participants, but only 76 participants had been hospitalised.","PN","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 80 out of 76 participants hospitalised. There is no evidence that the result was not biased by missing outcome data. However, it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes planned and reported and there were no inconsistencies. ","N","The time point is in accordance with an earlier version of the protocol.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","Amended phase 3 protocol was not available, but time point is in accordance with earlier version of protocol.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.42","Weinreich_2021 (preprint)_ICU admission_1.2g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","ICU admission at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (1678 participants randomised and 1484 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 1484 out of 1678 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes and there was only hospital admission planned. More outcomes/outcome combinations reported than initially planned. \"post-hoc\" analysis","PN","The time point is in accordance with an earlier version of the protocol.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","Amended phase 3 protocol was not available, but time point is in accordance with earlier version of protocol.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.43","Weinreich_2021 (preprint)_ICU admission_2.4g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","ICU admission at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838 PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, PCB: 24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, PCB: 68), and participants analysed (REGEN2.4g: 1355, REGEN1.2g: 736, PCB: 1341). ","NI","More participants missing than the ones not receiving or discontinuing treatment; but unclear who is missing.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, because it is unclear who was included in analysis set.",null,null,"N","Substantial difference in participants randomised vs. analysed in each group, while it is unclear why exactly missing participants (3029 participants randomised and 2696 participants analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","The participants listed as discontinued in Figure 1 are equally distributed between groups, but insufficient information is provided to reject the assumption that missingness could depend on the true value.","NI",null,"High","High","Data for this outcome was available for 2696 out of 3029 participants randomised. There is no evidence that the result was not biased by missing outcome data. However, there is insufficient information that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure.","PN","There is no indication that ascertainment differed between groups.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, but from the original trial protocol we could compare the outcomes and there was only hospital admission planned. More outcomes/outcome combinations reported than initially planned. \"post-hoc\" analysis","PN","The time point is in accordance with an earlier version of the protocol.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","Amended phase 3 protocol was not available, but time point is in accordance with earlier version of protocol.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.45","Weinreich_2021 (preprint)_AEall_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","adverse events any grade",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Investigators intented to evaluate safety in all treated patients, but it is unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838, REGN8.0g: 700, PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, REGN 8.0g: 11  PCB:24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, REGN8.0g: 34, PCB: 68), and participants analysed (REGEN2.4g: 1849, REGEN1.2g: 827, REGN8.0g: 1012, PCB: 1843).","NI","There were substantially more participants analysed than randomised/treated in the placebo group.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, as there were more participants analysed than even randomised or treated in the placebo group..",null,null,"N","It is unclear which participants were analysed in the placebo group, because there were more participants analysed than randomised/treated (1.2g: 838 randomised, 827 treated, 827 analysed; Placebo: 1500 randomised, 1476 treated, 1843 analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","It is unclear where the data of the participants who were analyzed in the placebo group came from.","NI",null,"High","High","Data for this outcome were analysed for more participants than randomised or treated. There is no evidence that the result was not biased by missing outcome data.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, and the original protocol did not specify the reporting of adverse events in its current form.","PN","There is no indication that the outcome measurement has been selected.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.45","Weinreich_2021 (preprint)_AEall_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","adverse events any grade",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Investigators intented to evaluate safety in all treated patients, but it is unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838, REGN8.0g: 700, PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, REGN 8.0g: 11  PCB:24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, REGN8.0g: 34, PCB: 68), and participants analysed (REGEN2.4g: 1849, REGEN1.2g: 827, REGN8.0g: 1012, PCB: 1843).","NI","There were substantially more participants analysed than randomised/treated in the placebo group.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, as there were more participants analysed than even randomised or treated in the placebo group..",null,null,"N","It is unclear which participants were analysed in the placebo group, because there were more participants analysed than randomised/treated (2.4g: 1529 randomised, 1512 treated, 1849 analysed; Placebo: 1500 randomised, 1476 treated, 1843 analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","It is unclear where the data of the participants who were analyzed in the placebo and treatment group came from.","NI",null,"High","High","Data for this outcome were analysed for more participants than randomised or treated. There is no evidence that the result was not biased by missing outcome data.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, and the original protocol did not specify the reporting of adverse events in its current form.","PN","There is no indication that the outcome measurement has been selected.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.46","Weinreich_2021 (preprint)_AEall_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","adverse events any grade",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Investigators intented to evaluate safety in all treated patients, but it is unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838, REGN8.0g: 700, PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, REGN 8.0g: 11  PCB:24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, REGN8.0g: 34, PCB: 68), and participants analysed (REGEN2.4g: 1849, REGEN1.2g: 827, REGN8.0g: 1012, PCB: 1843).","NI","There were substantially more participants analysed than randomised/treated in the placebo group.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, as there were more participants analysed than even randomised or treated in the placebo group..",null,null,"N","It is unclear which participants were analysed in the placebo group, because there were more participants analysed than randomised/treated (8.0g: 700 randomised, 689 treated, 1012 analysed; Placebo: 1500 randomised, 1476 treated, 1843 analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","It is unclear where the data of the participants who were analyzed in the placebo and treatment group came from.","NI",null,"High","High","Data for this outcome were analysed for more participants than randomised or treated. There is no evidence that the result was not biased by missing outcome data.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, and the original protocol did not specify the reporting of adverse events in its current form.","PN","There is no indication that the outcome measurement has been selected.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.49","Weinreich_2021 (preprint)_AE3_4_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","adverse events grade 3 and 4",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Investigators intented to evaluate safety in all treated patients, but it is unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838, REGN8.0g: 700, PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, REGN 8.0g: 11  PCB:24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, REGN8.0g: 34, PCB: 68), and participants analysed (REGEN2.4g: 1849, REGEN1.2g: 827, REGN8.0g: 1012, PCB: 1843).","NI","There were substantially more participants analysed than randomised/treated in the placebo group.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, as there were more participants analysed than even randomised or treated in the placebo group..",null,null,"N","It is unclear which participants were analysed in the placebo group, because there were more participants analysed than randomised/treated (1.2g: 838 randomised, 827 treated, 827 analysed; Placebo: 1500 randomised, 1476 treated, 1843 analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","It is unclear where the data of the participants who were analyzed in the placebo group came from.","NI",null,"High","High","Data for this outcome were analysed for more participants than randomised or treated. There is no evidence that the result was not biased by missing outcome data.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, and the original protocol did not specify the reporting of adverse events in its current form.","PN","There is no indication that the outcome measurement has been selected.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.49","Weinreich_2021 (preprint)_AE3_4_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","adverse events grade 3 and 4",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Investigators intented to evaluate safety in all treated patients, but it is unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838, REGN8.0g: 700, PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, REGN 8.0g: 11  PCB:24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, REGN8.0g: 34, PCB: 68), and participants analysed (REGEN2.4g: 1849, REGEN1.2g: 827, REGN8.0g: 1012, PCB: 1843).","NI","There were substantially more participants analysed than randomised/treated in the placebo group.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, as there were more participants analysed than even randomised or treated in the placebo group..",null,null,"N","It is unclear which participants were analysed in the placebo group, because there were more participants analysed than randomised/treated (2.4g: 1529 randomised, 1512 treated, 1849 analysed; Placebo: 1500 randomised, 1476 treated, 1843 analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","It is unclear where the data of the participants who were analyzed in the placebo and treatment group came from.","NI",null,"High","High","Data for this outcome were analysed for more participants than randomised or treated. There is no evidence that the result was not biased by missing outcome data.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, and the original protocol did not specify the reporting of adverse events in its current form.","PN","There is no indication that the outcome measurement has been selected.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.49","Weinreich_2021 (preprint)_AE3_4_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","adverse events grade 3 and 4",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Investigators intented to evaluate safety in all treated patients, but it is unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838, REGN8.0g: 700, PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, REGN 8.0g: 11  PCB:24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, REGN8.0g: 34, PCB: 68), and participants analysed (REGEN2.4g: 1849, REGEN1.2g: 827, REGN8.0g: 1012, PCB: 1843).","NI","There were substantially more participants analysed than randomised/treated in the placebo group.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, as there were more participants analysed than even randomised or treated in the placebo group..",null,null,"N","It is unclear which participants were analysed in the placebo group, because there were more participants analysed than randomised/treated (8.0g: 700 randomised, 689 treated, 1012 analysed; Placebo: 1500 randomised, 1476 treated, 1843 analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","It is unclear where the data of the participants who were analyzed in the placebo and treatment group came from.","NI",null,"High","High","Data for this outcome were analysed for more participants than randomised or treated. There is no evidence that the result was not biased by missing outcome data.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, and the original protocol did not specify the reporting of adverse events in its current form.","PN","There is no indication that the outcome measurement has been selected.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.53","Weinreich_2021 (preprint)_SAE_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","serious adverse events",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Investigators intented to evaluate safety in all treated patients, but it is unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838, REGN8.0g: 700, PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, REGN 8.0g: 11  PCB:24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, REGN8.0g: 34, PCB: 68), and participants analysed (REGEN2.4g: 1849, REGEN1.2g: 827, REGN8.0g: 1012, PCB: 1843).","NI","There were substantially more participants analysed than randomised/treated in the placebo group.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, as there were more participants analysed than even randomised or treated in the placebo group..",null,null,"N","It is unclear which participants were analysed in the placebo group, because there were more participants analysed than randomised/treated (1.2g: 838 randomised, 827 treated, 827 analysed; Placebo: 1500 randomised, 1476 treated, 1843 analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","It is unclear where the data of the participants who were analyzed in the placebo group came from.","NI",null,"High","High","Data for this outcome were analysed for more participants than randomised or treated. There is no evidence that the result was not biased by missing outcome data.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, and the original protocol did not specify the reporting of adverse events in its current form.","PN","There is no indication that the outcome measurement has been selected.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.53","Weinreich_2021 (preprint)_SAE_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","serious adverse events",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Investigators intented to evaluate safety in all treated patients, but it is unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838, REGN8.0g: 700, PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, REGN 8.0g: 11  PCB:24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, REGN8.0g: 34, PCB: 68), and participants analysed (REGEN2.4g: 1849, REGEN1.2g: 827, REGN8.0g: 1012, PCB: 1843).","NI","There were substantially more participants analysed than randomised/treated in the placebo group.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, as there were more participants analysed than even randomised or treated in the placebo group..",null,null,"N","It is unclear which participants were analysed in the placebo group, because there were more participants analysed than randomised/treated (2.4g: 1529 randomised, 1512 treated, 1849 analysed; Placebo: 1500 randomised, 1476 treated, 1843 analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","It is unclear where the data of the participants who were analyzed in the placebo and treatment group came from.","NI",null,"High","High","Data for this outcome were analysed for more participants than randomised or treated. There is no evidence that the result was not biased by missing outcome data.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, and the original protocol did not specify the reporting of adverse events in its current form.","PN","There is no indication that the outcome measurement has been selected.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.53","Weinreich_2021 (preprint)_SAE_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","serious adverse events",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequence was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS).\"","N","There are no baseline differences that would suggest a problem with randomisation: \"Among the mFAS population (n=4057), demographic and baseline medical characteristics were balanced between the placebo and REGEN-COV groups\".","Low","Low","Participants were randomised via central randomization scheme using an interactive web response system (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","According to original protocol participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\". In preprint it is mentioned that \"statistical analysis plan for the presented analysis was finalized prior to database lock and unblinding of phase 3 Cohort 1\".","NA",null,"NA",null,"NA",null,"N","Investigators intented to evaluate safety in all treated patients, but it is unclear who was included in analysis set. Number of randomized participants described (REGEN2.4g:1529 REGEN1.2g: 838, REGN8.0g: 700, PCB: 1500), who did not receive treatment (REGEN2.4g: 17, REGEN1.2g: 11, REGN 8.0g: 11  PCB:24, and participants that discontinued treatment (REGEN2.4g: 45, REGEN1.2g: 19, REGN8.0g: 34, PCB: 68), and participants analysed (REGEN2.4g: 1849, REGEN1.2g: 827, REGN8.0g: 1012, PCB: 1843).","NI","There were substantially more participants analysed than randomised/treated in the placebo group.","High","High","Both participants and those delivering the intervention were probably unaware of the intervention received. The analysis was inappropriate, as there were more participants analysed than even randomised or treated in the placebo group..",null,null,"N","It is unclear which participants were analysed in the placebo group, because there were more participants analysed than randomised/treated (8.0g: 700 randomised, 689 treated, 1012 analysed; Placebo: 1500 randomised, 1476 treated, 1843 analysed).","N","We found no evidence that the result was not biased by missing outcome data (no sensitivity analysis of imputing missing values, no comparison baseline characteristics of those missing from analysis).","NI","It is unclear where the data of the participants who were analyzed in the placebo and treatment group came from.","NI",null,"High","High","Data for this outcome were analysed for more participants than randomised or treated. There is no evidence that the result was not biased by missing outcome data.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Quote: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments\"","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The amended trial protocol for phase 3 was not available, and the original protocol did not specify the reporting of adverse events in its current form.","PN","There is no indication that the outcome measurement has been selected.","NI","Only the analysis for cohort 1 is provided, no SAP available to check whether this was predefined or not.","Some concerns","Some concerns","The data that produced this result was analysed and reported as planned in the original protocol. Amended phase 3 protocol was not available.",null,null,"High","High","For this outcome, there is a low risk of bias from the randomisation process and due to the measurement of the outcome. However, there are some concerns for bias due to selection of the reported results. There is a high risk of bias due to deviations from intended interventions and due to missing outcome data."]
["2021.07.05 14.57","Weinreich_2020_preprint_hospital admission or death_2.4g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 2.4g","Placebo","hospital admission or death","RR 0,43 (95% CI: 0,08 to 2,19)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequences was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS)\"","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were centrally randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","The protocol of the previously published version states: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study.\" The current preprint states only this: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments.\" and \"double-blind\"","NA",null,"NA",null,"NA",null,"Y","The mFAS (modified full analysis set) was used as pre-specified in previous protocol. Analysed as randomised if PCR-positive by central review.","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (532 participants randomised and 446 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 446 out of 532 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PN","SAP and protocol not provided for this preprint. Previous protocol: hospital admission only planned. More outcomes/outcome combinations reported than initially planned. \"post-hoc\" analysis","N","There is no indication that the outcome measurement has been selected among multiple measurements.","N","There is no indication that the result has been selected among multiple analyses.","Some concerns","Some concerns","SAP and protocol not provided for this preprint. There is no indication that the outcome measurement and the results have been selected.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias due to the randomisation process, due to deviations from the intended interventions, missing outcomes, measurement of the outcome. There are some concerns for risk of bias due to selection of reported results."]
["2021.07.05 14.57","Weinreich_2020_preprint_hospital admission or death_8.0g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 8.0g","Placebo","hospital admission or death","RR 0,21 (95% CI: 0,02 to 1,79)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequences was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS)\"","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were centrally randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","The protocol of the previously published version states: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study.\" The current preprint states only this: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments.\" and \"double-blind\"","NA",null,"NA",null,"NA",null,"Y","The mFAS (modified full analysis set) was used as pre-specified in previous protocol. Analysed as randomised if PCR-positive by central review.","NA",null,"Low","Low","Both participants and those delivering the intervention were probably unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (533 participants randomised and 450 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 450 out of 533 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PN","SAP and protocol not provided for this preprint. Previous protocol: hospital admission only planned. More outcomes/outcome combinations reported than initially planned. \"post-hoc\" analysis","N","There is no indication that the outcome measurement has been selected among multiple measurements.","N","There is no indication that the result has been selected among multiple analyses.","Some concerns","Some concerns","SAP and protocol not provided for this preprint. There is no indication that the outcome measurement and the results have been selected.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias due to the randomisation process, due to deviations from the intended interventions, missing outcomes, measurement of the outcome. There are some concerns for risk of bias due to selection of reported results."]
["2021.07.05 16.36","Weinreich_2020_preprint_AE3_4_2.4g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 2.4g","Placebo","adverse event grade 3 and 4","RR 0,76 (95% CI: 0,17 to 3,37)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequences was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS)\"","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were centrally randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","The protocol of the previously published version states: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study.\" The current preprint states only this: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments.\" and \"double-blind\"","NA",null,"NA",null,"NA",null,"Y","Yes: \"Safety was assessed in patients in the FAS who received study drug (active or placebo).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (532 participants randomised and 520 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 520 out of 532 participants randomised.",null,null,"NI","\"Events listed here were not present at baseline or were an exacerbation of a preexisting condition that occurred during the observation period, which is defined as the time from administration of REGEN-COV or placebo to the final follow-up visit.\" - the protocol and preprint state \"for Phase 1 only\", thus it is unclear how many patients/which time frame was included.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Some concerns","There is no information whether measurement of the outcome was appropriate, but it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","SAP and protocol not provided for this preprint. The result analysed was in accordance with the previous protocol.","PN","There is no indication that the outcome measurement has been selected among multiple measurements.","PN","There is no indication that the result has been selected among multiple analyses.","Low","Low","The data that produced this result was analysed in accordance with the previous protocol. There is no indication that the outcome measurement and the results have been selected.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias due to the randomisation process, due to deviations from the intended interventions, missing outcomes and due to selection of reported results. However, there are some concerns for risk of bias due to measurement of the outcome."]
["2021.07.05 16.36","Weinreich_2020_preprint_AE3_4_8.0g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 8.0g","Placebo","adverse event grade 3 and 4","RR 0,50 (95% CI: 0,09 to 2,73)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequences was random and concealed according to the trial protocol published with the previous publication of this study (Weinreich 2020): \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS)\"","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were centrally randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","The protocol of the previously published version states: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study.\" The current preprint states only this: \"The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments.\" and \"double-blind\"","NA",null,"NA",null,"NA",null,"Y","Yes: \"Safety was assessed in patients in the FAS who received study drug (active or placebo).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (533 participants randomised and 522 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 522 out of 533 participants randomised.",null,null,"NI","\"Events listed here were not present at baseline or were an exacerbation of a preexisting condition that occurred during the observation period, which is defined as the time from administration of REGEN-COV or placebo to the final follow-up visit.\" - the protocol and preprint state \"for Phase 1 only\", thus it is unclear how many patients/which time frame was included.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Some concerns","There is no information whether measurement of the outcome was appropriate, but it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","SAP and protocol not provided for this preprint. The result analysed was in accordance with the previous protocol.","PN","There is no indication that the outcome measurement has been selected among multiple measurements.","PN","There is no indication that the result has been selected among multiple analyses.","Low","Low","The data that produced this result was analysed in accordance with the previous protocol. There is no indication that the outcome measurement and the results have been selected.",null,null,"Some concerns","Some concerns","For this outcome, there is a low risk of bias due to the randomisation process, due to deviations from the intended interventions, missing outcomes and due to selection of reported results. However, there are some concerns for risk of bias due to measurement of the outcome."]
["2021.07.05 14.04","Weinreich_2020_preprint_SAE_2.4g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 2.4g","Placebo","serious adverse events (SAE)","RR 0,68 (95% CI: 0,19 to 2,37)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequences was random and concealed according to the trial: \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS)\"","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were centrally randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\".","NA",null,"NA",null,"NA",null,"Y","Yes: \"Safety was assessed in patients in the FAS who received study drug (active or placebo).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (533 participants randomised and 522 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 520 out of 532 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the previous protocol.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","SAP and protocol not provided for this preprint. Outcome SAE in line with previous protocol.","PN","There is no indication that the outcome measurement has been selected among multiple measurements.","PN","There is no indication that the result has been selected among multiple analyses","Low","Low","The data that produced this result was analysed in accordance with the previous protocol. There is no indication that the outcome measurement and the results have been selected.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.05 14.04","Weinreich_2020_preprint_SAE_8.0g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 8.0g","Placebo","serious adverse events (SAE)","RR 0,34 (95% CI: 0,07 to 1,65)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","The allocation sequences was random and concealed according to the trial: \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS)\"","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were centrally randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\".","NA",null,"NA",null,"NA",null,"Y","Yes: \"Safety was assessed in patients in the FAS who received study drug (active or placebo).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (533 participants randomised and 522 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 520 out of 532 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in the previous protocol.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","SAP and protocol not provided for this preprint. Outcome SAE in line with previous protocol.","PN","There is no indication that the outcome measurement has been selected among multiple measurements.","PN","There is no indication that the result has been selected among multiple analyses","Low","Low","The data that produced this result was analysed in accordance with the previous protocol. There is no indication that the outcome measurement and the results have been selected.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.05 19.17","RECOVERY_(preprint)_mortality_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","Mortality at day 28","RR 0,94 (95% CI: 0,87 to 1,02)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"using web-based simple (unstratified) randomisation with allocation concealed until after randomisation\".","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were randomised via web-based randomisation and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"Y","Y","Participants and people delivering the intervention were aware of intervention received, as this is an open label trial.","NI","Concomitant treatments were distributed evenly across treatment groups.","NA",null,"NA",null,"Y","Yes, an intention-to-treat analysis was performed.","NA",null,"Some concerns","High","Both participants and those delivering the intervention were aware of intervention received and nearly all participants received assigned intervention. The analysis was appropriate. Because of no standard treatment for COVID-19, control group may have received concomitant treatment more quickly. ",null,null,"Y","Data for this outcome was available for all participants (9785 participants randomised and 9785 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for all 9785 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured and analysed as described in the protocol and SAP.","N","No differences in measurement between groups.","NI","The outcomes were collected by the research team, \"investigators\" were blind. Unclear whether these were the same people.","N","The outcome mortality is objective and its assessment cannot be influenced by the knowledge of intervention received, as it would not change the fact of being dead or alive.","NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. It was unclear whether outcome assessors were unaware of the intervention received, but it is unlikely that knowledge of intervention received could have affected outcome measurement.",null,null,"Y","The result analysed were in accordance to the protocol and SAP available.","N","Endpoint measured and reported as planned in protocol.","N","Endpoint measured and reported as planned in protocol.","Low","Low","The data that produced this result was analysed and reported as planned in the protocol and SAP.",null,null,"High","High","For this outcome, there is a low risk of bias due to the randomisation process, due to missing outcomes, due to measurement of the outcome and due to selection of reported results. However, there is high risk of bias due to deviations from the intended interventions."]
["2021.07.05 19.27","RECOVERY_(preprint)_clinical progression_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","IMV or death","RR 0,96 (95% CI: 0,90 to 1,04)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"using web-based simple (unstratified) randomisation with allocation concealed until after randomisation\".","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were randomised via web-based randomisation and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"Y","Y","Participants and people delivering the intervention were aware of intervention received, as this is an open label trial.","NI","Concomitant treatments were distributed evenly across treatment groups.","NA",null,"NA",null,"Y","Yes, an intention-to-treat analysis was performed.","NA",null,"Some concerns","High","Both participants and those delivering the intervention were aware of intervention received and nearly all participants received assigned intervention. The analysis was appropriate. Because of no standard treatment for COVID-19, control group may have received concomitant treatment more quickly. ",null,null,"Y","Data for this outcome was available for all participants (9785 participants randomised and 9198 participants analysed): \"Analyses exclude those on invasive mechanical ventilation at randomisation\" (587 participants).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 9198 out of 9785 participants randomised. 587 participants were on mechanical ventilation at randomisation and therefore excluded.",null,null,"PN","The outcome measurement is an appropriate measure and was measured and analysed as described in the protocol and SAP.","PN","No indication that there were differences in measurement between groups.","NI","The outcomes were collected by the research team, \"investigators\" were blind. Unclear whether these were the same people.","N","The outcome IMV or death is objective and its assessment cannot be influenced by the knowledge of intervention received.","NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. It was unclear whether outcome assessors were unaware of the intervention received, but it is unlikely that knowledge of intervention received could have affected outcome measurement.",null,null,"Y","The result analysed were in accordance to the protocol and SAP available.","PN","Endpoint measured and reported as planned in protocol.","PN","Endpoint measured and reported as planned in protocol.","Low","Low","The data that produced this result was analysed and reported as planned in the protocol and SAP.",null,null,"High","High","For this outcome, there is a low risk of bias due to the randomisation process, due to missing outcomes, due to measurement of the outcome and due to selection of reported results. However, there is high risk of bias due to deviations from the intended interventions."]
["2021.07.05 19.35","RECOVERY_(preprint)_hospital discharge_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","Hospital discharge (alive) from day 28","RR 1,01 (95% CI: 0,98 to 1,04)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"using web-based simple (unstratified) randomisation with allocation concealed until after randomisation\".","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were randomised via web-based randomisation and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"Y","Y","Participants and people delivering the intervention were aware of intervention received, as this is an open label trial.","NI","Concomitant treatments were distributed evenly across treatment groups.","NA",null,"NA",null,"Y","Yes, an intention-to-treat analysis was performed.","NA",null,"Some concerns","High","Both participants and those delivering the intervention were aware of intervention received and nearly all participants received assigned intervention. The analysis was appropriate. Because of no standard treatment for COVID-19, control group may have received concomitant treatment more quickly. ",null,null,"Y","Data for this outcome was available for all participants (9785 participants randomised and 9785 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for all 9785 participants randomised.",null,null,"PN","The outcome was only prespecified as time-to-event outcome according to the protocol and SAP, but we assume that the outcome was measured appropriately.","PN","No indication that there were differences in measurement between groups.","NI","The outcomes were collected by the research team, \"investigators\" were blind. Unclear whether these were the same people.","PN","It is unlikely that the outcome assessment has been influenced by knowledge of intervention received.","NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. It was unclear whether outcome assessors were unaware of the intervention received, but it is unlikely that knowledge of intervention received could have affected outcome measurement.",null,null,"PY","The outcome was prespecified as time-to-event outcome according to the protocol and SAP.","PN","There is no indication for multiple eligible outcome measurements.","PN","The outcome was reported additionally, as it was planned as a time-to-event analysis. There is no indication that one analysis was reported selectively.","Low","Low","The outcome was pre-specified and there is no indication for selective reporting.",null,null,"High","High","For this outcome, there is a low risk of bias due to the randomisation process, due to missing outcomes, due to measurement of the outcome and due to selection of reported results. However, there is high risk of bias due to deviations from the intended interventions."]
["2021.07.05 19.41","RECOVERY_(preprint)_thromboembolic events_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","Thromboembolic events","RR 1,03 (95% CI: 0,86 to 1,22)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"using web-based simple (unstratified) randomisation with allocation concealed until after randomisation\".","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were randomised via web-based randomisation and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"Y","Y","Participants and people delivering the intervention were aware of intervention received, as this is an open label trial.","NI","Concomitant treatments were distributed evenly across treatment groups.","NA",null,"NA",null,"Y","Yes, an intention-to-treat analysis was performed.","NA",null,"Some concerns","High","Both participants and those delivering the intervention were aware of intervention received and nearly all participants received assigned intervention. The analysis was appropriate. Because of no standard treatment for COVID-19, control group may have received concomitant treatment more quickly. ",null,null,"Y","Data for this outcome was available for all participants (9785 participants randomised and 9785 participants analysed.","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for all 9785 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured and analysed as described in the protocol and SAP.","PN","No indication that there were differences in measurement between groups.","NI","The outcomes were collected by the research team, \"investigators\" were blind. Unclear whether these were the same people.","PN","It is unlikely that the outcome assessment has been influenced by knowledge of intervention received.","NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. It was unclear whether outcome assessors were unaware of the intervention received, but it is unlikely that knowledge of intervention received could have affected outcome measurement.",null,null,"PY","The result analysed were in accordance to the protocol and SAP available.","PN","Endpoint measured and reported as planned in protocol.","PN","Endpoint measured and reported as planned in protocol.","Low","Low","The data that produced this result was analysed and reported as planned in the protocol and SAP.",null,null,"High","High","For this outcome, there is a low risk of bias due to the randomisation process, due to missing outcomes, due to measurement of the outcome and due to selection of reported results. However, there is high risk of bias due to deviations from the intended interventions."]
["2021.07.05 19.46","RECOVERY_(preprint)_need for dialysis_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","Need for dialysis","RR 1,03 (95% CI: 0,85 to 1,25)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"using web-based simple (unstratified) randomisation with allocation concealed until after randomisation\".","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were randomised via web-based randomisation and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"Y","Y","Participants and people delivering the intervention were aware of intervention received, as this is an open label trial.","NI","Concomitant treatments were distributed evenly across treatment groups.","NA",null,"NA",null,"Y","Yes, an intention-to-treat analysis was performed.","NA",null,"Some concerns","High","Both participants and those delivering the intervention were aware of intervention received and nearly all participants received assigned intervention. The analysis was appropriate. Because of no standard treatment for COVID-19, control group may have received concomitant treatment more quickly. ",null,null,"Y","Data for this outcome was available for all participants (9785 participants randomised and 9670 participants analysed. Analyses exclude those on renal replacement therapy at randomisation.\"","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 9670 out of 9785 participants randomised. Participants on renal replacement therapy at randomisation were therefore excluded.",null,null,"PN","The outcome measurement is an appropriate measure and was measured and analysed as described in the protocol and SAP.","PN","No indication that there were differences in measurement between groups.","NI","The outcomes were collected by the research team, \"investigators\" were blind. Unclear whether these were the same people.","PN","It is unlikely that the outcome assessment has been influenced by knowledge of intervention received.","NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. It was unclear whether outcome assessors were unaware of the intervention received, but it is unlikely that knowledge of intervention received could have affected outcome measurement.",null,null,"PY","The result analysed were in accordance to the protocol and SAP available.","PN","Endpoint measured and reported as planned in protocol.","PN","Endpoint measured and reported as planned in protocol.","Low","Low","The data that produced this result was analysed and reported as planned in the protocol and SAP.",null,null,"High","High","For this outcome, there is a low risk of bias due to the randomisation process, due to missing outcomes, due to measurement of the outcome and due to selection of reported results. However, there is high risk of bias due to deviations from the intended interventions."]
["2021.07.29 18.03","Dougan_2021_mortality_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","Mortality at day 28","RR 0,05 (95% CI: 0,00 to 0,81)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation (see Table 1, Table S3).","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"In this double-blind study, neither participants, investigators, nor the sponsor study team were aware of treatment assignments prior to the final data base lock at the conclusion of the study arm.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed.","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and an appropriate analysis was performed.",null,null,"Y","Data for this outcome was available for nearly all participants (1049 participants randomised vs. 1035 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 1035 out of 1049 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The result analysed was in accordance to the original protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the original protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 11.15","Dougan_2021_hospital admission or death_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29","RR 0,30 (95% CI: 0,16 to 0,59)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation (see Table 1, Table S3).","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","According to the original protocol articipants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed.","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and an appropriate analysis was performed.",null,null,"Y","Data for this outcome was available for all participants (1035 participants randomised vs. 1035 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 1035 out of 1049 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Time point in accordance with other time points in the study.","N","Endpoint analysed as planned.","Low","Low","The data that produced this result were analysed in accordance to the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 11.38","Dougan_2021_length of hospital stay_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation (see Table 1, Table S3).","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","According to the protocol articipants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed.","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and an appropriate analysis was performed.",null,null,"Y","Data for this outcome was available for all participants who were hospitalised.","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for all hospitalised participants.",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in the protocol.","PN","Differences in measurement between groups were unlikely.","N","Outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","No, multiple outcome measurements are unlikely.","N","Endpoint analysed as planned.","Low","Low","The data that produced this result were analysed in accordance to the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 15.29","Dougan_2021_viral clearance at day 3_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29","RR 2,12 (95% CI: 1,16 to 3,86)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation (see Table 1, Table S3).","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","According to the protocol articipants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed.","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and an appropriate analysis was performed.",null,null,"Y","Data for this outcome was available for nearly all participants (1035 randomised, 968 analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for nearly all participants (968 out of 1035 participants randomised).",null,null,"PN","The outcome was measurement is an appropriate measure and was measured as described in the protocol.\r\nThe outcome was provided with a Kaplan-Meier graph including the number of events per day, which we used to calculate cumulative frequency of viral clearance","PN","Differences in measurement between groups were unlikely.","N","Outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The Kaplan-Meier curve was in accordance to the protocol and statistical analysis plan available. We used it to calculate cumulative frequency of viral clearance.","N","No, multiple outcome measurements are unlikely.","N","Endpoint analysed as planned.","Low","Low","We used data from Kaplan-Meier curve to calculate cumulative frequency of viral clearance.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 15.29","Dougan_2021_viral clearance at day 7_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29","RR 1,81 (95% CI: 1,27 to 2,60)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation (see Table 1, Table S3).","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","According to the protocol articipants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed.","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and an appropriate analysis was performed.",null,null,"Y","Data for this outcome was available for nearly all participants (1035 randomised, 968 analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for nearly all participants (968 out of 1035 participants randomised).",null,null,"PN","The outcome was measurement is an appropriate measure and was measured as described in the protocol.\r\nThe outcome was provided with a Kaplan-Meier graph including the number of events per day, which we used to calculate cumulative frequency of viral clearance","PN","Differences in measurement between groups were unlikely.","N","Outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The Kaplan-Meier curve was in accordance to the protocol and statistical analysis plan available. We used it to calculate cumulative frequency of viral clearance.","N","No, multiple outcome measurements are unlikely.","N","Endpoint analysed as planned.","Low","Low","We used data from Kaplan-Meier curve to calculate cumulative frequency of viral clearance.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.30 15.29","Dougan_2021_viral clearance at day 15_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29","RR 1,34 (95% CI: 1,07 to 1,67)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation (see Table 1, Table S3).","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","According to the protocol articipants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed.","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and an appropriate analysis was performed.",null,null,"Y","Data for this outcome was available for nearly all participants (1035 randomised, 968 analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for nearly all participants (968 out of 1035 participants randomised).",null,null,"PN","The outcome was measurement is an appropriate measure and was measured as described in the protocol.\r\nThe outcome was provided with a Kaplan-Meier graph including the number of events per day, which we used to calculate cumulative frequency of viral clearance","PN","Differences in measurement between groups were unlikely.","N","Outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The Kaplan-Meier curve was in accordance to the protocol and statistical analysis plan available. We used it to calculate cumulative frequency of viral clearance.","N","No, multiple outcome measurements are unlikely.","N","Endpoint analysed as planned.","Low","Low","We used data from Kaplan-Meier curve to calculate cumulative frequency of viral clearance.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.07 10.16","Dougan_2021_AEall_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","adverse events all grades","RR 1,15 (95% CI: 0,83 to 1,59)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation (see Table 1, Table S3).","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","According to the original protocol articipants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed.","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and an appropriate analysis was performed.",null,null,"Y","Data for this outcome was available for all participants (1035 participants randomised vs. 1035 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 1035 out of 1049 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The result analysed was in accordance to the original protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the original protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.07.29 18.12","Dougan_2021_SAE_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","serious adverse events","RR 1,40 (95% CI: 0,45 to 4,37)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation (see Table 1, Table S3).","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"PN","PN","According to the original protocol articipants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed.","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and an appropriate analysis was performed.",null,null,"Y","Data for this outcome was available for all participants (1035 participants randomised vs. 1035 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 1035 out of 1049 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in the original protocol.","PN","Differences in measurement between groups were unlikely.","N","Outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was probably appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"PY","The result analysed was in accordance to the original protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the original protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]

{"sheet":"Summary","index":2,"n_rows":104,"n_cols":27,"rows_kept":104,"cut":false,"hidden":false,"merged":[]}
["Unique ID","Reviewer","Study ID","Reference","Experimental","Comparator","Outcome","Result","Aim","Effect of adhering to intervention?","Weight","Randomization process","Deviations from intended interventions","Mising outcome data","Measurement of the outcome","Selection of the reported result","Overall Bias",null,null,null,null,"Randomization process","Deviations from intended interventions","Mising outcome data","Measurement of the outcome","Selection of the reported result","Overall Bias"]
["Lundgren_2020_mortality","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Mortality at day 28","RR 1.39 (95% CI: 0.40 to 4.83)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Assignment to intervention (the 'intention-to-treat' effect)"]
["Lundgren (preprint)_2021_mortality_90","NK, CH","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Mortality at day 90","HR 1.09 (95% CI: 0.49 to 2.43)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Total number of study = 103",0,0,0,0,2.4,2.4]
["Lundgren_2020_development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","RR 1.17 (95% CI: 0.75 to1.85)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,null,94.2,74.8,79.599999999999994,98.1,69.900000000000006,57.3]
["Lundgren_2020_Hospital-discharge_day5","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Hospital discharge at day 5","RR 0.98 (95% CI: 0.81 to 1.19)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,null,0,0,0,1.9,30.1,11.7]
["Lundgren_2020_Hospital-discharge_TTE","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Hospital discharge TTE up to 26 October 2020","HR 0.97 (95% CI: 0.78 to 1.20)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,null,5.8,25.2,20.399999999999999,0,0,31.1]
["Lundgren_2020_development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","RR 1.49 (95% CI: 0.50 to 4.46)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_SAE","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","serious adverse events up to day 28","RR 0.93 (95% CI: 0.27 to 3.14)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Total number of study = 0"]
["Lundgren (preprint)_2021_SAE_90","NK, CH","ACTIV-3",null,"Bamlanivimab 7g","Placebo","serious adverse events up to day 90","RR 0.70 (95% CI: 0.29 to 1.67)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_AE_3and4","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Grade 3 and 4 adverse events up to day 28","RR 1.27 (95% CI: 0.81 to 1.98)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren (preprint)_2021_sustained recovery","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Grade 3 and 4 adverse events up to day 28","RR 1.27 (95% CI: 0.81 to 1.98)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_neurological-dysfunction: transient ischemic events","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: transient ischemic events","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_neurological-dysfunction: acute delirium CVA","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: acute delirium CVA","RR 3.71 (95%CI: 0.42 to 32.80)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_neurological-dysfunction: cerebrovascular event","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: cerebrovascular event","RR 0.31 (95% CI: 0.01 to 7.53)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_thromboembolic events","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Thromboembolic events","RR 2.78 (95% CI: 0.29 to 26.44)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_Renal dysfunction (or need for dialysis) at day 28","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Renal dysfunction (or need for dialysis) at day 28","RR 4.64 (95% CI: 0.22 to 95.83)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_mortality_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_mortality_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_mortality_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_mortality_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","Mortality at day 28",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"High","Low","Low","Low","Low","High"]
["Gottlieb_2020_hospital-admission_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","Admission to hospital","RR 0.17 (95% CI: 0.02 to 1.33)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_hospital-admission_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","admission to hospital at day 29","RR 0.32 (95% CI: 0.07 to 1.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_hospital-admission_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","admission to hospital at day 29","RR 0.34 (95% CI: 0.08 to 1.56)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_hospital-admission_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","admission to hospital at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"High","Low","Low","Low","Low","High"]
["Gottlieb_2020_viral-clearance7_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","viral clearance at day 7","RR 0.92 (95% CI: 0.43 to 1.93)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance7_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","viral clearance at day 7","RR 1.08 (95% CI: 0.53 to 2.18)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance7_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","viral clearance at day 7","RR 0.73 (95% CI: 0.33 to 1.65)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance7_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","viral clearance at day 7",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"High","Low","Low","Low","Low","High"]
["Gottlieb_2020_viral-clearance15_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","viral clearance at day 15","RR 1.07 (95% CI: 0.69 to 1.66)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance15_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","viral clearance at day 15","RR 1.20 (95% CI: 0.79 to 1.82)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance15_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","viral clearance at day 15","RR 1.03 (95% CI: 0.66 to 1.61)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance15_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","viral clearance at day 15",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"High","Low","Low","Low","Low","High"]
["Gottlieb_2020_AEall_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","adverse events all grades","RR 0.99 (95% CI: 0.66 to 1.50)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_AEall_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","adverse events all grades","RR 0.90 (95% CI: 0.59 to 1.38)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_AEall_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","adverse events all grades","RR 0.81 (95% CI: 0.52 to 1.27)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_AEall_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","adverse events all grades",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"High","Low","Low","Low","Low","High"]
["Gottlieb_2020_SAE_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","serious adverse events (SAEs)","RR 0.51 (95% CI: 0.02 to 12.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_SAE_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","serious adverse events (SAEs)","RR 0.48 (95% CI: 0.02 to 11.78)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_SAE_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","serious adverse events (SAEs)","RR 0.51 (95% CI: 0.02 to 12.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_SAE_Bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","serious adverse events (SAEs)",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"High","Low","Low","Low","Low","High"]
["Gupta_2021 (preprint)_mortality","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","Mortality at day 29","RR 0,33 (95% CI: 0,01 to 8,18)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Gupta_2021 (preprint)_clinical progression day 29: oxy","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","development of severe symptoms according to WHO scale (>=5, incl. death)","RR 0,11 (95% CI: 0,02 to 0,45)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Gupta_2021 (preprint)_clinical progression day 29: IMV","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","development of severe symptoms according to WHO scale (>=7, IMV, incl. death)","RR 0,14 (95% CI: 0,01 to 2,76)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Gupta_2021 (preprint)_hospital admission","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","hospitalised or death >= 24 hours for any cause","RR 0,14 (95% CI: 0,04 to 0,48)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Gupta_2021 (preprint)_ICU admission","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","admission to ICU for any cause","RR 0,09 (95% CI: 0,01 to 1,64)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Gupta_2021 (preprint)_AEall","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","adverse events any grade","RR 0,87 (95% CI: 0,66 to 1,16)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Gupta_2021 (preprint)_AE grade 3_4","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","adverse events grade 3 and 4","RR 0,26 (95% CI: 0,12 to 0,60)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Gupta_2021 (preprint)_SAE","NK, CH","COMET-ICE",null,"Sotrovimab","Placebo","serious adverse events","RR 0,27 (95% CI: 0,12 to 0,63)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Eom_2021 (preprint)_mortality_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_mortality_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_clinical progression day 28_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","Clinical progression at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_clinical progression day 28_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","Clinical progression at day 28","RR 3,00 (95% CI: 0,12 to 72,80)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_hospital admission_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","hospital admission","RR 0,45 (95% CI: 0,14 to 1,42)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_hospital admission_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","hospital admission","RR 0,56 (95% CI: 0,19 to 1,60)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_ICU admission_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","ICU admission","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_ICU admission_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","ICU admission","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_viral clearance day14_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","viral clearance day 14","RR 1,12 (95% CI: 0,91 to 1,38)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_viral clearance day14_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","viral clearance day 14","RR 1,10 (95% CI: 0,89 to 1,35)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_AEall_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","adverse events all grades","RR 0,96 (95% CI: 0,64 to 1,43)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_AEall_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","adverse events all grades","RR 0,79 (95% CI: 0,52 to 1,22)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_AE_3 and 4_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","adverse events grade 3 and 4","RR 2,62 (95% CI: 0,52 to 13,21)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_AE_3 and 4_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","adverse events grade 3 and 4","RR 2,00 (95% CI: 0,37 to 10,70)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_SAE_40mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (40mg/kg)","Placebo","treatment emergent serious adverse events","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Eom_2021 (preprint)_SAE_80mg/kg","NK, CH","Eom_2021 (preprint)",null,"CT-P59 (80mg/kg)","Placebo","treatment emergent serious adverse events","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Weinreich_2021 (preprint)_mortality_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","Mortality at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_mortality_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","Mortality at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_mortality_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","Mortality at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_clinical progression_1.2g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","IMV at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_clinical progression_2.4g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","IMV at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_hospital admission_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","hospital admission or death at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_hospital admission_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","hospital admission or death at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_hospital admission_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","hospital admission or death at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_length of hospital stay_1.2g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","Length of hospital stay",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_length of hospital stay_2.4g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","Length of hospital stay",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_ICU admission_1.2g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","ICU admission at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_ICU admission_2.4g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","ICU admission at day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_AEall_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","adverse events any grade",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_AEall_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","adverse events any grade",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_AEall_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","adverse events any grade",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_AE3_4_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","adverse events grade 3 and 4",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_AE3_4_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","adverse events grade 3 and 4",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_AE3_4_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","adverse events grade 3 and 4",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_SAE_1.2g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 1.2g","Placebo","serious adverse events",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_SAE_2.4g","VP, NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 2.4g","Placebo","serious adverse events",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2021 (preprint)_SAE_8.0g","NK, CH","Weinreich_2021 (preprint)",null,"REGN-COV 8.0g","Placebo","serious adverse events",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","High","Low","Some concerns","High"]
["Weinreich_2020_preprint_hospital admission or death_2.4g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 2.4g","Placebo","hospital admission or death","RR 0,43 (95% CI: 0,08 to 2,19)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Weinreich_2020_preprint_hospital admission or death_8.0g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 8.0g","Placebo","hospital admission or death","RR 0,21 (95% CI: 0,02 to 1,79)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Some concerns","Some concerns"]
["Weinreich_2020_preprint_AE3_4_2.4g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 2.4g","Placebo","adverse event grade 3 and 4","RR 0,76 (95% CI: 0,17 to 3,37)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Some concerns"]
["Weinreich_2020_preprint_AE3_4_8.0g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 8.0g","Placebo","adverse event grade 3 and 4","RR 0,50 (95% CI: 0,09 to 2,73)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Some concerns","Low","Some concerns"]
["Weinreich_2020_preprint_SAE_2.4g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 2.4g","Placebo","serious adverse events (SAE)","RR 0,68 (95% CI: 0,19 to 2,37)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Weinreich_2020_preprint_SAE_8.0g","NK, CH","Weinreich 2020",null,"REGN-CoV-2 8.0g","Placebo","serious adverse events (SAE)","RR 0,34 (95% CI: 0,07 to 1,65)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["RECOVERY_(preprint)_mortality_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","Mortality at day 28","RR 0,94 (95% CI: 0,87 to 1,02)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["RECOVERY_(preprint)_clinical progression_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","IMV or death","RR 0,96 (95% CI: 0,90 to 1,04)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["RECOVERY_(preprint)_hospital discharge_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","Hospital discharge (alive) from day 28","RR 1,01 (95% CI: 0,98 to 1,04)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["RECOVERY_(preprint)_thromboembolic events_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","Thromboembolic events","RR 1,03 (95% CI: 0,86 to 1,22)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["RECOVERY_(preprint)_need for dialysis_8.0g","NK, CH","RECOVERY",null,"REGN-COV 8.0g","Standard of care","Need for dialysis","RR 1,03 (95% CI: 0,85 to 1,25)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","High","Low","Low","Low","High"]
["Dougan_2021_mortality_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","Mortality at day 28","RR 0,05 (95% CI: 0,00 to 0,81)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Dougan_2021_hospital admission or death_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29","RR 0,30 (95% CI: 0,16 to 0,59)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Dougan_2021_length of hospital stay_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29",null,"assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Dougan_2021_viral clearance at day 3_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29","RR 2,12 (95% CI: 1,16 to 3,86)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Dougan_2021_viral clearance at day 7_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29","RR 1,81 (95% CI: 1,27 to 2,60)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Dougan_2021_viral clearance at day 15_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","hospital admission or death by day 29","RR 1,34 (95% CI: 1,07 to 1,67)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Dougan_2021_AEall_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","adverse events all grades","RR 1,15 (95% CI: 0,83 to 1,59)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Dougan_2021_SAE_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","serious adverse events","RR 1,40 (95% CI: 0,45 to 4,37)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]

{"sheet":"Figure (ITT)","index":3,"n_rows":37,"n_cols":16,"rows_kept":37,"cut":false,"hidden":false,"merged":[]}
["Intention-to-treat","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]
[null,"Lundgren_2020_mortality","ACTIV-3","Bamlanivimab 7g","Placebo","Mortality at day 28",1,null,null,null,null,null,null,null,null,"Low risk"]
[null,"Lundgren_2020_development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","ACTIV-3","Bamlanivimab 7g","Placebo","Development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)",1,null,null,null,null,null,null,null,null,"Some concerns"]
[null,"Lundgren_2020_Hospital-discharge_day5","ACTIV-3","Bamlanivimab 7g","Placebo","Hospital discharge at day 5",1,null,null,null,null,null,null,null,null,"High risk"]
[null,"Lundgren_2020_Hospital-discharge_TTE","ACTIV-3","Bamlanivimab 7g","Placebo","Hospital discharge TTE up to 26 October 2020",1]
[null,"Lundgren_2020_development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","ACTIV-3","Bamlanivimab 7g","Placebo","Development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)",1,null,null,null,null,null,null,null,"D1","Randomisation process"]
[null,"Lundgren_2020_SAE","ACTIV-3","Bamlanivimab 7g","Placebo","serious adverse events up to day 28",1,null,null,null,null,null,null,null,"D2","Deviations from the intended interventions"]
[null,"Lundgren_2020_AE_3and4","ACTIV-3","Bamlanivimab 7g","Placebo","Grade 3 and 4 adverse events up to day 28",1,null,null,null,null,null,null,null,"D3","Missing outcome data"]
[null,"Lundgren_2020_neurological-dysfunction: transient ischemic events","ACTIV-3","Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: transient ischemic events",1,null,null,null,null,null,null,null,"D4","Measurement of the outcome"]
[null,"Lundgren_2020_neurological-dysfunction: acute delirium CVA","ACTIV-3","Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: acute delirium CVA",1,null,null,null,null,null,null,null,"D5","Selection of the reported result"]
[null,"Lundgren_2020_neurological-dysfunction: cerebrovascular event","ACTIV-3","Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: cerebrovascular event",1]
[null,"Lundgren_2020_thromboembolic events","ACTIV-3","Bamlanivimab 7g","Placebo","Thromboembolic events",1]
[null,"Lundgren_2020_Renal dysfunction (or need for dialysis) at day 28","ACTIV-3","Bamlanivimab 7g","Placebo","Renal dysfunction (or need for dialysis) at day 28",1]
[null,"Gottlieb_2020_mortality_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","Mortality at day 28",1]
[null,"Gottlieb_2020_mortality_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","Mortality at day 28",1]
[null,"Gottlieb_2020_mortality_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","Mortality at day 28",1]
[null,"Gottlieb_2020_mortality_bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and Etesevimab","Placebo","Mortality at day 28",1]
[null,"Gottlieb_2020_hospital-admission_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","Admission to hospital",1]
[null,"Gottlieb_2020_hospital-admission_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","admission to hospital at day 29",1]
[null,"Gottlieb_2020_hospital-admission_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","admission to hospital at day 29",1]
[null,"Gottlieb_2020_hospital-admission_bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and etesevimab","Placebo","admission to hospital at day 29",1]
[null,"Gottlieb_2020_viral-clearance7_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","viral clearance at day 7",1]
[null,"Gottlieb_2020_viral-clearance7_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","viral clearance at day 7",1]
[null,"Gottlieb_2020_viral-clearance7_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","viral clearance at day 7",1]
[null,"Gottlieb_2020_viral-clearance7_bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and etesevimab","Placebo","viral clearance at day 7",1]
[null,"Gottlieb_2020_viral-clearance15_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","viral clearance at day 15",1]
[null,"Gottlieb_2020_viral-clearance15_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","viral clearance at day 15",1]
[null,"Gottlieb_2020_viral-clearance15_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","viral clearance at day 15",1]
[null,"Gottlieb_2020_AEall_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","adverse events all grades",1]
[null,"Gottlieb_2020_AEall_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","adverse events all grades",1]
[null,"Gottlieb_2020_AEall_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","adverse events all grades",1]
[null,"Gottlieb_2020_AEall_bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and etesevimab","Placebo","adverse events all grades",1]
[null,"Gottlieb_2020_SAE_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","serious adverse events (SAEs)",1]
[null,"Gottlieb_2020_SAE_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","serious adverse events (SAEs)",1]
[null,"Gottlieb_2020_SAE_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","serious adverse events (SAEs)",1]
[null,"Gottlieb_2020_SAE_Bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and etesevimab","Placebo","serious adverse events (SAEs)",1]
[null,"Weinreich_2020_SAE","Weinreich 2020","REGN-CoV-2 (2.4g and 8.0g)","Placebo","serious adverse events (SAE)",1]

{"sheet":"Figure (PP)","index":4,"n_rows":1,"n_cols":13,"rows_kept":1,"cut":false,"hidden":false,"merged":[]}
["Per-protocol","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]

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["Unique ID","Lundgren_2020_mortality","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 311 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 311 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_Hospital-discharge_day5","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Hospital discharge at day 5","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_Hospital-discharge_TTE","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Hospital discharge TTE up to 26 October 2020","Results","hazard ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, a modified intention to treat analysis was performed: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 311 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 311 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_SAE","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events up to day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_AE_3and4","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Grade 3 and 4 adverse events up to day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_neurological-dysfunction: transient ischemic events","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Neurological dysfunction at day 28: transient ischemic events","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_neurological-dysfunction: acute delirium CVA","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Neurological dysfunction at day 28: acute delirium CVA","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_neurological-dysfunction: cerebrovascular event","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Neurological dysfunction at day 28: cerebrovascular event","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_thromboembolic events","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Thromboembolic events","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_Renal dysfunction (or need for dialysis) at day 28","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Renal dysfunction (or need for dialysis) at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_mortality_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains. "]
[]
[]
["Unique ID","Gottlieb_2020_mortality_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 263 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_mortality_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_mortality_bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and Etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 268 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_hospital-admission_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Admission to hospital","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_hospital-admission_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","admission to hospital at day 29","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 263 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_hospital-admission_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","admission to hospital at day 29","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_hospital-admission_bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","admission to hospital at day 29","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 268 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance7_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 7","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 244 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 244 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance7_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 7","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised and 246 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 246 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance7_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 7","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 244 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 244 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance7_bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 7","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised and 245 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 245 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance15_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 15","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 223 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 223 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance15_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 15","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 229 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 229 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance15_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 15","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 226 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 226 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_AEall_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","adverse events all grades","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_AEall_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","adverse events all grades","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 263 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_AEall_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","adverse events all grades","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_AEall_bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","adverse events all grades","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 268 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_SAE_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAEs)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_SAE_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAEs)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised and 263 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 263 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_SAE_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAEs)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_SAE_Bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAEs)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised and 268 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 268 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Weinreich_2020_SAE","Study ID","Weinreich 2020","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","REGN-CoV-2 (2.4g and 8.0g)","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAE)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS)\""]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation."]
[null,"Risk of bias judgement",null,null,"Low","Participants were centrally randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\"."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed: \"The full analysis set (FAS) includes all randomized patients and is based on the treatment allocated (as randomized).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised and 269 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 269 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]

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{"sheet":"Check","index":7,"n_rows":0,"n_cols":0,"rows_kept":0,"cut":false,"hidden":false,"merged":[]}

{"sheet":"Print_format (PP)","index":8,"n_rows":32,"n_cols":6,"rows_kept":32,"cut":false,"hidden":true,"merged":[[31,1,31,3],[21,0,26,0],[21,1,21,3],[22,1,22,3],[26,1,26,3],[23,1,23,3],[25,1,25,3],[24,1,24,3],[29,1,29,3],[27,0,30,0],[27,1,27,3],[28,1,28,3],[30,1,30,3],[14,1,14,3],[15,1,15,3],[16,0,20,0],[16,1,16,3],[17,1,17,3],[18,1,18,3],[20,1,20,3],[19,1,19,3],[18,5,19,5],[24,5,25,5],[4,1,4,3],[5,0,8,0],[5,1,5,3],[5,5,6,5],[6,1,6,3],[7,1,7,3],[8,1,8,3],[9,5,10,5],[10,1,10,3],[11,1,11,3],[12,1,12,3],[13,1,13,3],[9,0,15,0],[9,1,9,3]]}
["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","adhering to intervention (the 'per-protocol' effect)","The effect of adhering to intervention…"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1 Were participants aware of their assigned intervention during the trial?"]
[null,"2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important non-protocol interventions balanced across intervention groups?"]
[null,"2.4. [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?"]
[null,"2.5. [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?"]
[null,"2.6. If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

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["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

{"sheet":"Function Tab","index":10,"n_rows":12,"n_cols":19,"rows_kept":12,"cut":false,"hidden":true,"merged":[]}
[null,"Journal article(s)","NA","Yes",null,"1.1 Was the allocation sequence random?",null,"2.1 Were participants aware of their assigned intervention during the trial?","2.1 Were participants aware of their assigned intervention during the trial?",null,"3.1 Were data for this outcome available for all, or nearly all, participants randomized?","Individually Randomized, Parallel Group Trials","4.1 Was the method of measuring the outcome inappropriate?","assignment to intervention (the 'intention-to-treat' effect)","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,null,"occurance of non-protocol interventions"]
["NA","Trial protocol","Favours experimental ","No (Please include reasons in the note)","Y","1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?","Low","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,"3.2 If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?",null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?","adhering to intervention (the 'per-protocol' effect)","5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,null,"failures in implementing the intervention that could have affected the outcome"]
["Y","Statistical analysis plan (SAP)","Favours comparator ",null,"PY","1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?","High","2.3 [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important nonprotocol interventions balanced across intervention groups?","2.3 If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?",null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,"4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?",null,"5.3 ... multiple eligible analyses of the data?",null,null,null,"non-adherence to their assigned intervention by trial participants"]
["PY","Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Towards null ",null,"PN",null,"Some concerns","2.4 [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?","2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
["PN","Company-owned trial registry record (e.g. GSK Clinical Study Register record)","Away from null ",null,"N",null,null,"2.5 [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?","2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
["N","“Grey literature” (e.g. unpublished thesis)","Unpredictable",null,"NI",null,null,"2.6 If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?","2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
["NI","Conference abstract(s) about the trial",null,null,null,null,null,null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Regulatory document (e.g. Clinical Study Report, Drug Approval Package)"]
[null,"Research ethics application"]
[null,"Grant database summary (e.g. NIH RePORTER, Research Councils UK Gateway to Research)"]
[null,"Personal communication with trialist"]
[null,"Personal communication with the sponsor"]