A Phase 3, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Ropeginterferon Alfa-2b in Patients with Moderate COVID-19
et al., Infectious Diseases and Therapy, doi:10.1007/s40121-024-00992-5, NCT05770466, May 2024
RCT 132 hospitalized moderate COVID-19 patients in Taiwan showing higher rates of viral clearance or discharge by day 11 with ropeginterferon alfa-2b. The ropeginterferon alfa-2b group also showed higher rates of improvement in lung infiltration on day 5 and WHO clinical progression scores on day 8. There was no significant difference in mortality.
|
risk of death, 3.4% higher, RR 1.03, p = 1.00, treatment 2 of 87 (2.3%), control 1 of 45 (2.2%).
|
|
risk of mechanical ventilation, 89.8% lower, RR 0.10, p = 0.04, treatment 0 of 87 (0.0%), control 3 of 45 (6.7%), NNT 15, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
|
|
risk of oxygen therapy, 3.4% higher, RR 1.03, p = 1.00, treatment 32 of 87 (36.8%), control 16 of 45 (35.6%).
|
|
risk of no recovery, 3.9% lower, RR 0.96, p = 1.00, treatment 13 of 87 (14.9%), control 7 of 45 (15.6%), NNT 163, Ct<30 and no discharge, day 22.
|
|
risk of no recovery, 48.3% lower, RR 0.52, p = 0.31, treatment 5 of 87 (5.7%), control 5 of 45 (11.1%), NNT 19, Ct<30 and no discharge, day 15.
|
|
risk of no recovery, 59.8% lower, RR 0.40, p = 0.05, treatment 7 of 87 (8.0%), control 9 of 45 (20.0%), NNT 8.4, Ct<30 and no discharge, day 11.
|
|
risk of no recovery, 25.3% lower, RR 0.75, p = 0.47, treatment 13 of 87 (14.9%), control 9 of 45 (20.0%), NNT 20, Ct<30 and no discharge, day 8.
|
|
risk of no recovery, 6.6% lower, RR 0.93, p = 0.70, treatment 56 of 87 (64.4%), control 31 of 45 (68.9%), NNT 22, Ct<30 and no discharge, day 5.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Liu et al., 21 May 2024, Randomized Controlled Trial, Taiwan, peer-reviewed, mean age 63.0, 20 authors, study period April 2022 - January 2023, trial NCT05770466 (history).
Contact: whsheng@ntu.edu.tw, 13258@s.tmu.edu.tw.
A Phase 3, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Ropeginterferon Alfa-2b in Patients with Moderate COVID-19
Infectious Diseases and Therapy, doi:10.1007/s40121-024-00992-5
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
Author Contributions. The study was designed by Wang-Huei Sheng, Kang-Yun Lee, Po-Hao Feng, Wang-Da Liu, Albert Qin, and PharmaEssentia clinical team. We would like to thank Jason Liao and Sheena Lin for their help with the statistical design and method. 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, Kang-Yun Lee, and Wang-Huei Sheng recruited the patients and collected the data. Chan-Yen Tsai, Albert Qin, Weichung Joe Shih, Po-Hao Feng, Wang-Da Liu, Kang-Yun Lee, and Wang-Huei Sheng analyzed the data and wrote the initial manuscript. All authors interpreted the data and were involved in writing, reviewing, and approving the manuscript. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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