Favipiravir Versus Arbidol for Clinical Recovery Rate in Moderate and Severe Adult COVID-19 Patients: A Prospective, Multicenter, Open-Label, Randomized Controlled Clinical Trial
Chang Chen, Yi Zhang, Jianying Huang, Ping Yin, Zhenshun Cheng, Jianyuan Wu, Song Chen, Yongxi Zhang, Bo Chen, Mengxin Lu, Yongwen Luo, Lingao Ju, Jingyi Zhang, Xinghuan Wang
Frontiers in Pharmacology, doi:10.3389/fphar.2021.683296
Background: In addition to supportive therapy, antiviral therapy is an effective treatment for coronavirus disease 2019 . Objective: To compare the efficacy and safety of favipiravir and umifenovir (Arbidol) to treat COVID-19 patients. Methods: We conducted a prospective, randomized, controlled, open-label multicenter trial involving adult patients with COVID-19. Enrolled patients with initial symptoms within 12 days were randomly assigned in a 1:1 ratio to receive conventional therapy plus Arbidol (200 mg*3/day) or favipiravir (1600 mg*2/first day followed by 600 mg*2/day) for 7 days. The primary outcome was the clinical recovery rate at day 7 of drug administration (relief for pyrexia and cough, respiratory frequency ≤24 times/min; oxygen saturation ≥98%). Latency to relief for pyrexia and cough and the rate of auxiliary oxygen therapy (AOT) or noninvasive mechanical ventilation (NMV)/mechanical ventilation (MV) were the secondary outcomes. Safety data were collected for 17 days. Results: A total of 240 enrolled COVID-19 patients underwent randomization; 120 patients were assigned to receive favipiravir (116 assessed), and 120 patients were assigned to receive Arbidol (120 assessed). The clinical recovery rate at day 7 of drug administration did not significantly differ between the favipiravir group (71/116) and Arbidol group (62/120) (p 0.1396, difference in recovery rate: 0.0954; 95% CI: −0.0305∼0.2213). Favipiravir contributed to relief for both pyrexia (difference: 1.70 days, p < 0.0001) and cough (difference: 1.75 days, p < 0.0001). No difference was observed in the
ETHICS STATEMENT The studies involving human participants were reviewed and approved by The study was approved by the Institutional Ethics Committee (No. 2020040). The patients/participants provided their written informed consent to participate in this study.
AUTHOR CONTRIBUTIONS CC, YiZ, JH, and PY contributed equally to this paper. CC, JH, JW, and XW conceived and designed the study. CC, YiZ, JH, PY, ZC, JW, and YoZ contributed to patient recruitment, data collection, data analysis and data interpretation. CC, YiZ, JH, PY, SC, BC, ML, YL, and LJ wrote the first draft of the manuscript. CC, JH, and XW provided administrative, technical, or material support. JH and XW supervised the study. CC, YiZ, JH, JW, YoZ, BC, JZ, and XW contributed to the critical revision of the manuscript for important intellectual content. All authors reviewed and approved the final version of the manuscript.
FUNDING This work was supported by the National Key Research and Development Program of China (2020YFC0844400). The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
SUPPLEMENTARY MATERIAL The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fphar.2021.683296/ full#supplementary-material Conflict of Interest: Author YZ is employed by the company Euler..
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