Efficacy and Safety of Pegylated Interferon alfa-2b in Moderate COVID-19: A phase II, randomized, controlled, open-label study

Pandit, Anuja; Bhalani, Nirav; Bhushan, B.L. Shashi; Koradia, Parshottam; Gargiya, Shweta; Bhomia, Vinay; Kansagra, Kevinkumar

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 COVID-19. METHODS: In this phase 2, randomized, open-label study, adult subjects aged >18 years with RT-PCR confirmed COVID-19 with moderate symptoms were randomized in a 1:1 to receive PEG IFN-α2b plus SOC, or SOC alone. The primary endpoint was improvement in clinical status on day 15, measured by WHO 7-point ordinal scale. RESULTS: Total 40 subjects were randomized to PEG IFN-α2b plus SOC (n = 20) and SOC (n = 20). Overall, 19 (95.00%) subjects in PEG IFN-α2b plus SOC had achieved clinical improvement on day 15 compared to 13 (68.42%) subjects in SOC (p < 0.05). Overall, 80% and 95% of subjects in the PEG IFN-α2b plus SOC group had a negative RT-PCR result on day 7 and day 14, respectively as compared to 63% and 68% in the SOC group. Adverse events (AEs) were reported for 11 subjects in the PEG IFN-α2b plus SOC group and 8 subjects in the SOC group. All reported AEs were mild. CONCLUSION: The significant improvement in clinical status on day 15 is likely due to faster viral reduction compared to SOC with the PEG IFN-α2b treated moderate COVID-19 subjects showing a difference as early as day 7 and becoming significant by day 14.