The Reset-α Study: A Double Blind, Randomized, Multi Centre, Phase III Trial for the Efficacy and Safety of Thymosin α-1 (Tα1) in Sepsis Patients
Authors/Creators
- 1. Department of Medical Affairs, Gufic Biosciences Ltd, SM House, 11 Sahakar Road, Vile Parle (East), Mumbai, Maharashtra, India.
- 2. Department of Pulmonary and Critical Care Medicine, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical Rd, Rohtak, Haryana, India.
- 3. Department of Critical Care Medicine, Medicover Hospitals, Behind Cyber Tower, Hitech City, Madhapur, Hyderabad-, Telangana, India.
- 4. Department of Anesthesiology , S N Medical College Agra, Uttar Pradesh, India.
- 5. Department of General Medicine, Government Medical College (GMC), Jalgaon, Maharashtra, India.
- 6. Department of General Medicine, Mahatma Gandhi Memorial hospital, Warangal, Telangana, India.
- 7. Department of General Medicine, King George hospital, Andhra medical College, Maharanipeta, Visakhapatnam, Andhra Pradesh, India.
- 8. Department of Critical Care Medicine, Ozone Hospitals, 25, road number 1, Narsimhapur colony, HUDA colony, Kothapet, Hyderabad, Telangana, India.
- 9. Department of Medicine & Critical Care, Aarvy hospital, 530/18, Jail Rd, Civil Lines, Gurugram Haryana, India.
Description
Aims and Background: Thymosin alpha 1 (Tα1) has shown promise as an adjuvant treatment for sepsis. This study evaluated the efficacy and safety of Tα1 versus placebo, both combined with standard care, in patients with sepsis.
Methods: This was a multicenter, randomized, double-blind, placebo-controlled Phase III trial. Patients received four injections of Tα1 (2 vials twice daily) or placebo subcutaneously from Day 1 to Day 7 along with standard care. The primary endpoint was the change in Sequential Organ Failure Assessment (SOFA) score. Secondary endpoints included incidence of emerging infections, pathogen clearance rate, ICU/ventilator/vasoactive-agent-free days, changes in lymphocyte markers (CD4/CD8, NLR), TNFα , CRP, mortality, and adverse events (AEs).
Results: Of 131 screened, 123 patients were enrolled across 10 sites. Mean SOFA score reduction was greater in the Tα1 arm (-3.5 ±1.7) versus placebo (-1.13 ±1.2), showing statistical significance. ICU and vasoactive-agent-free days were also significantly higher in the Tα1 arm. Both groups showed reductions in TNF, NLR, and CRP; however, only the Tα1 group showed statistically significant reductions from baseline on Day 7. Mortality was lower in the Tα1 group. Treatment-emergent AEs occurred in 48.4% of Tα1 patients and 72.1% of placebo patients, mostly mild and resolved without sequelae. Septic shock occurred in 3 (Tα1) vs. 5 (placebo) patients.
Conclusion: Tα1 appears to be a safe and effective adjunct to standard care in sepsis, demonstrating significant improvements in organ dysfunction and clinical outcomes.