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

https://doi.org/10.1016/j.ijid.2021.03.015

CTRI/2020/06/026087- 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-alpha2b plus SOC, or SOC alone. The primary endpoint was improvement in clinical status on day 15, measured by WHO 7-point ordinal scale.  Total 40 subjects were randomized to PEG IFN-alpha2b plus SOC (n = 20) and SOC (n = 20). Overall, 19 (95.00%) subjects in PEG IFN-alpha2b 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-alpha2b 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-alpha2b plus SOC group and 8 subjects in the SOC group. All reported AEs were mild. The significant improvement in clinical status on day 15 is likely due to faster viral reduction compared to SOC with the PEG IFN-alpha2b treated moderate COVID-19 subjects showing a difference as early as day 7 and becoming significant by day 14.

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