Efficacy and safety of pegylated interferon alfa-2b in moderate COVID-19: A phase II, randomized, controlled, open-label study

Objective: To evaluate the efficacy and safety of pegylated interferon alfa-2b (PEG IFN-?2b) 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-?2b plus SOC, or SOC alone. The primary endpoint was improvement in clinical status on day 15, measured by the WHO 7-point ordinal scale. Results: Forty subjects were randomized to PEG IFN-?2b plus SOC (n = 20) and SOC (n = 20). Overall, 19 (95.0 0%) subjects in PEG IFN-?2b 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-?2b plus SOC group had a negative RT-PCR result on day 7 and day 14, respectively, compared to 63% and 68% in the SOC group. Adverse events (AEs) were reported for eleven subjects in the PEG IFN-?2b plus SOC group and eight 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-?2b treated moderate COVID-19 subjects showing a difference as early as day seven and becoming significant by day 14. ? 2021 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-ncnd/4.0/).