No Statistically Apparent Difference in Antiviral Effectiveness Observed Among Ribavirin Plus Interferon-Alpha, Lopinavir/Ritonavir Plus Interferon-Alpha, and Ribavirin Plus Lopinavir/Ritonavir Plus Interferon-Alpha in Patients With Mild to Moderate Coronavirus Disease 2019: Results of a Randomized, Open-Labeled Prospective Study
Yin-Qiu Huang, Sheng-Quan Tang, Xiao-Lei Xu, Yan-Ming Zeng, Xiao-Qing He, Yao Li, Vijay Harypursat, Yan-Qiu Lu, Yan Wan, Lu Zhang, Qiang-Zhong Sun, Nan-Nan Sun, Gui-Xue Wang, Zhong-Ping Yang, Yao-Kai Chen
Frontiers in Pharmacology, doi:10.3389/fphar.2020.01071
Background: Currently, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread globally, causing an unprecedented pandemic. However, there is no specific antiviral therapy for coronavirus disease 2019 (COVID-19). We conducted a clinical trial to compare the effectiveness of three antiviral treatment regimens in patients with mild to moderate COVID-19. Methods: This was a single-center, randomized, open-labeled, prospective clinical trial. Eligible patients with mild to moderate COVID-19 were randomized into three groups: ribavirin (RBV) plus interferon-a (IFN-a), lopinavir/ritonavir (LPV/r) plus IFN-a, and RBV plus LPV/r plus IFN-a at a 1:1:1 ratio. Each patient was invited to participate in a 28-d follow-up after initiation of an antiviral regimen. The outcomes include the difference in median interval to SARS-CoV-2 nucleic acid negativity, the proportion of patients with SARS-CoV-2 nucleic acid negativity at day 14, the mortality at day 28, the proportion of patients re-classified as severe cases, and adverse events during the study period. Results: In total, we enrolled 101 patients in this study. Baseline clinical and laboratory characteristics of patients were comparable among the three groups. In the analysis of
ETHICS STATEMENT The studies involving human participants were reviewed and approved by the ethics committee of Chongqing Public Health Medical Center (2020-002-01-KY). The patients/participants provided their written informed consent to participate in this study.
AUTHOR CONTRIBUTIONS Y-KC and Z-PY conceived the study. LZ, Y-MZ, Q-ZS, N-NS, and YW collected data. S-QT, YL, G-XW, and X-LX analyzed data. Y-QH, S-QT, and Y-KC interpreted the results. Y-QH and S-QT wrote the manuscript. VH, X-QH, and Y-QL edited and revised the article.
Conflict of Interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as potential conflicts of interest.
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