Abstract
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 the WHO 7-point ordinal scale.
Results: Forty 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, compared to 63% and 68% in the SOC group. Adverse events (AEs) were reported for eleven subjects in the PEG IFN-α2b 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-α2b treated moderate COVID-19 subjects showing a difference as early as day seven and becoming significant by day 14.
Keywords: Antiviral; COVID-19; Coronavirus; Pegylated interferon alfa-2b (PEG IFN-α2b).
【저자키워드】 COVID-19, coronavirus, Antiviral, Pegylated interferon alfa-2b (PEG IFN-α2b)., 【초록키워드】 Open-label, Antiviral, Phase 2, interferon, Symptom, RT-PCR, Moderate COVID-19, clinical status, adverse events, Randomized, Clinical improvement, Mild, Efficacy and safety, moderate, Ordinal Scale, primary endpoint, interferon alfa-2b, reduction, Standard of care, Adverse, subject, 7-point ordinal scale, IFN-α2b, negative RT-PCR, event, adult subjects, Seven, eight subjects, evaluate, reported, treated, faster, the WHO, receive, 1:1, adult subject, AEs, eight subject, 【제목키워드】 Open-label, interferon, Randomized, moderate,