Efficacy and Safety of Pegylated Interferon-α2b in Moderate COVID-19: A phase 3, randomized, comparator-controlled, open-label study

L, Shashi Bhushan B; 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

OBJECTIVE: To evaluate the efficacy and safety of pegylated interferon alfa-2b (PEG IFN-α2b) along with the standard of care (SOC) in subjects with moderate Corona Virus Disease-19 (COVID-19). METHODS: In this study, adult subjects with confirmed COVID-19 and moderate signs and symptoms were randomized in a 1:1 ratio to receive either PEG IFN-α2b + SOC or, SOC alone. The primary endpoint was a 2-point improvement in clinical status on day 11, measured by the World Health Organisation 7-point ordinal scale. RESULTS: 250 subjects were randomized to the PEG IFN-α2b + SOC (n = 120) and the SOC (n = 130) arms. The PEG IFN vs SOC arm results for the proportion of subjects with a 2-point improvement 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 the arms, no clinically significant changes in lab parameters, and the safety profile was similar. 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 virus.