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.
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.
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