Efficacy and safety of pegylated interferon-α2b in moderate COVID-19: a phase 3, randomized, comparator-controlled, open-label study

• Published in: International journal of infectious diseases Vol. 111; pp. 281 - 287
• Main Authors: Bhushan B L, Shashi, Wanve, Sunil, Koradia, Parshottam, Bhomia, Vinay, Soni, Pravin, Chakraborty, Sisir, Khobragade, Akash, Joshi, Shashank, Mendiratta, Sanjeev Kumar, Kansagra, Kevin Kumar, Parihar, Anurag, Sharma, Sunil, Patel, Jatin
• Format: Journal Article
• Language: English
• Published: Canada Elsevier Ltd 01.10.2021; The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases; Elsevier
• Subjects: Adult; Antiviral Agents - adverse effects; COVID-19; Humans; Interferon alpha-2; Interferon-alpha - adverse effects; Moderate subjects; Pegylated interferon alpha-2b (PEG IFN-α2b); Phase 3; Polyethylene Glycols - adverse effects; Recombinant Proteins; SARS-CoV-2; Treatment Outcome; Pegylated interferon alpha-2b (PEG IFN-α2b); Phase 3; SARS-CoV-2; Moderate subjects
• ISSN: 1201-9712; 1878-3511; 1878-3511
• DOI: 10.1016/j.ijid.2021.08.044

•Coronavirus disease-19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).•Interferons have been shown to be crucial for treating SARS-CoV-2 in patients with COVID-19.•There is an urgent need to develop effective therapy for COVID-19 to battle the pandemic.•This study evaluated the efficacy and safety of pegylated interferon-α2b in patients with moderate COVID-19.•Pegylated interferon represents a viable treatment option and can limit the spread of SARS-CoV-2. To evaluate the efficacy and safety of pegylated interferon alpha-2b (PEG IFN-α2b) administered in conjunction with the standard of care (SOC) in subjects with moderate coronavirus disease-19 (COVID-19). In this study, adult subjects with confirmed moderate COVID-19 were randomized in a 1:1 ratio to receive either PEG IFN-α2b + SOC or SOC alone. The primary endpoint was a two-point improvement in clinical status on Day 11, measured by the World Health Organization's seven-point ordinal scale. Of 250 subjects, 120 were randomized to the PEG IFN-α2b + SOC arm and 130 were randomized to the SOC arm. The results for the PEG IFN + SOC arms vs the SOC arm for the proportion of subjects with a two-point improvement in the seven-point ordinal scale 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 arms, and no clinically significant changes in laboratory parameters. The safety profile was similar in both arms. 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 severe acute respiratory syndrome coronavirus-2.