A Phase 3, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Ropeginterferon Alfa-2b in Patients with Moderate COVID-19

Wang Da Liu, Po Hao Feng, Chien Yu Cheng, Chun Liang Chou, Chih Hsin Lee, Min Chi Lu, Po Yu Liu, Mei Hui Lee, Chun Hsing Liao, Mei Chuan Chen, Cheng Pin Chen, Shang Fu Hsu, Yu Tien Tzeng, Yi Chun Lin, Tsong Yih Ou, Albert Qin, Chan Yen Tsai, Weichung Joe Shih, Kang Yun Lee, Wang Huei Sheng

Research output: Contribution to journalArticlepeer-review


Introduction: Ropeginterferon alfa-2b is a novel mono-pegylated proline-interferon. This clinical study aimed to evaluate its antiviral efficacy of ropeginterferon alfa-2b against SARS-CoV-2 infection. Methods: This is a multicenter, randomized, open-label study. Adult patients with confirmed SARS-CoV-2 infection with initial cycle threshold (Ct) value < 30 and symptom onset within 4 days were enrolled. Eligible patients were randomized in a 2:1 ratio to receive a single 250-µg dose of ropeginterferon alfa-2b subcutaneously plus standard of care (SOC) or to receive SOC alone. The primary endpoint was the proportion of patients with a negative RT-PCR result for SARS-CoV-2 or discharged from the hospital before Day 8. Change in clinical status based on the World Health Organization (WHO) clinical progression scale and pulmonary infiltrations through chest radiograph were also evaluated. Results: A total of 132 patients were enrolled and treated with study medication. Higher percentages of patients who achieved Ct ≥ 30 or were discharged from the hospital were observed on Day 8 and every other time point of assessment, i.e., Days 5, 11, 15, and 22, in the ropeginterferon alfa-2b group compared to the SOC alone group. However, the difference was statistically significant on Day 11 but not on Day 8. The primary endpoint was not met. The ropeginterferon alfa-2b group showed a higher improvement rate in lung infiltration on Day 5 (27.6% vs. 0.0%, p = 0.0087) and a higher improvement rate in WHO clinical progression scores on Day 8 (69.4% vs. 35.3%, p = 0.03) than those in the SOC group. No ropeginterferon alfa-2b-related serious adverse event was observed. Conclusion: Our data show that ropeginterferon alfa-2b with SOC shortened the duration of SARS-CoV-2 shedding compared with SOC alone. In addition, ropeginterferon alfa-2b as an additional therapy could be beneficial by improving lung infiltration.

Original languageEnglish
Pages (from-to)1575-1588
Number of pages14
JournalInfectious Diseases and Therapy
Issue number7
Publication statusAccepted/In press - 2024


  • Clinical trial
  • Coronavirus, ropeginterferon alfa-2b
  • Interferon
  • SARS-CoV-2

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases


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