Efficacy and safety of pegylated interferon-α2b in moderate COVID-19: a phase 3, randomized, comparator-controlled, open-label study. (October 2021)

• Record Type: Journal Article
• Authors: Bhushan B L, Shashi; Wanve, Sunil; Koradia, Parshottam; Bhomia, Vinay; Soni, Pravin; Chakraborty, Sisir; Khobragade, Akash; Joshi, Shashank; Mendiratta, Sanjeev Kumar; Kansagra, Kevin Kumar; Parihar, Anurag; Sharma, Sunil; Patel, Jatin
• Is Part Of: International journal of infectious diseases. Volume 111(2021)
• Page Start: 281
• Page End: 287
• Publication Date: 2021-10
• Subjects: Pegylated interferon alpha-2b (PEG IFN-α2b) -- SARS-CoV-2 -- Phase 3 -- Moderate subjects; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2021.08.044
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: Coronavirus disease-19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Interferons have been shown to be crucial for treating SARS-CoV-2 in patients with COVID-19. There is an urgent need to develop effective therapy for COVID-19 to battle the pandemic. This study evaluated the efficacy and safety of pegylated interferon-α2b in patients with moderate COVID-19. Pegylated interferon represents a viable treatment option and can limit the spread of SARS-CoV-2. Abstract: Objective: To evaluate the efficacy and safety of pegylated interferon alpha-2b (PEG IFN-α2b) administered in conjunction with the standard of care (SOC) in subjects with moderate coronavirus disease-19 (COVID-19). Methods: In this study, adult subjects with confirmed moderate COVID-19 were randomized in a 1:1 ratio to receive either PEG IFN-α2b + SOC or SOC alone. The primary endpoint was a two-point improvement in clinical status on Day 11, measured by the World Health Organization's seven-point ordinal scale. Results: Of 250 subjects, 120 were randomized to the PEG IFN-α2b + SOC arm and 130 were randomized to the SOC arm. The results for the PEG IFN + SOC arms vs the SOC arm for the proportion of subjects with a two-point improvement in the seven-point ordinal scale were 80.36% vs 68.18% ( P =0.037) on Day 8, 91.60% vs 92.56% ( P =0.781) on Day 11, and 94.12% vs 95.93% ( P =0.515) on Day 15. There was a time-dependent decrease in the biomarkers in both arms, and no clinically significant changes in laboratory parameters. The safety profile was similar in both arms. Conclusion: PEG IFN-α2b induced early viral clearance, improved the clinical status, and decreased the duration of supplemental oxygen. It provides a viable treatment option and can limit the spread of severe acute respiratory syndrome coronavirus-2.