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Published November 22, 2021 | Version v1
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Sero-epidemiological survey on the impact of smoking on SARS-CoV-2 infection and COVID-19 outcomes − The Troina Study Protocol

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Background: After the global spread of SARS-CoV-2, research has highlighted several aspects of the pandemic, focusing on clinical features and risk factors associated with infection and disease severity. However, emerging results on the role of smoking in SARS-CoV-2 infection susceptibility or COVID-19 outcomes are conflicting, and their robustness remains uncertain.

Objective: In this context, this study aims at quantifying the proportion of SARS-CoV-2 antibody seroprevalence, studying the changes in antibody levels over time, and analyzing the association between the biochemically verified smoking status and SARS-CoV-2 infection.

Methods: The research design involves a 6-month prospective cohort study with a serial sampling of the same individuals. Each participant will be surveyed about their demographics and COVID-19–related information, and blood sampling will be collected upon recruitment and at specified follow-up time points (ie, after 8 and 24 weeks). Blood samples will be screened for the presence of SARS-CoV-2–specific antibodies and serum cotinine, being the latter of the principal metabolite of nicotine, which will be used to assess participants’ smoking status.

Results: The study is ongoing. It aims to find a higher antibody prevalence in individuals at high risk for viral exposure (ie, health care personnel) and to refine current estimates on the association between smoking status and SARS-CoV-2/COVID-19.

Conclusions: The added value of this research is that the current smoking status of the population to be studied will be biochemically verified to avoid the bias associated with self-reported smoking status. As such, the results from this survey may provide an actionable metric to study the role of smoking in SARS-CoV-2 infection and COVID-19 outcomes, and therefore to implement the most appropriate public health measures to control the pandemic. Results may also serve as a reference for future clinical research, and the methodology could be exploited in public health sectors and policies.

International Registered Report Identifier (IRRID): DERR1-10.2196/32285

JMIR Res Protoc 2021;10(11):e32285

Notes

This investigator research protocol was sponsored by ECLAT SRL, a spin-off of the University of Catania, through a grant from the Foundation for a Smoke-Free World, a US nonprofit 501(c)(3) private foundation with a mission to end smoking in this generation. The Foundation accepts charitable gifts from PMI Global Services Inc.; under the Foundation's Bylaws and Pledge Agreement with PMI Global Services Inc., the Foundation is independent from PMI Global Services Inc. and the tobacco industry. The contents, selection, and presentation of facts, as well as any opinions expressed herein are the sole responsibility of the authors and under no circumstances shall be regarded as reflecting the positions of the Foundation for a Smoke-Free World, Inc. ECLAT SRL is a research-based company from the University of Catania that delivers solutions to global health problems with special emphasis on harm minimization and technological innovation.

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