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Favipiravir Versus Arbidol for Clinical Recovery Rate in Moderate and Severe Adult COVID-19 Patients: A Prospective, Multicenter, Open-Label, Randomized Controlled Clinical Trial


Posted: 2021-09-20 19:00:00
Front Pharmacol . 2021 Sep 2;12:683296. doi: 10.3389/fphar.2021.683296. eCollection 2021. Chang Chen 1 2 , Yi Zhang 3 4 , Jianying Huang 1 5 , Ping Yin 6 , Zhenshun Cheng 7 , Jianyuan Wu 1 5 , Song Chen 8 , Yongxi Zhang 9 , Bo Chen 1 5 , Mengxin Lu 8 , Yongwen Luo 8 , Lingao Ju 8 , Jingyi Zhang 10 , Xinghuan Wang 1 5 8 11 Affiliations Expand Affiliations 1 Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, China. 2 Department of Anesthesiology, Zhongnan Hospital of Wuhan University, Wuhan, China. 3 Center for Life Sciences, Peking University, Beijing, China. 4 Euler Technology, Beijing, China. 5 Wuhan Leishenshan Hospital, Wuhan, China. 6 Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 7 Department of Respiratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China. 8 Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China. 9 Department of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China. 10 Department of Cardiology, The Third People's Hospital of Hubei Province, Wuhan, China. 11 Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China. Item in Clipboard Chang Chen et al. Front Pharmacol. 2021. Show details Display options Display options Format Front Pharmacol . 2021 Sep 2;12:683296. doi: 10.3389/fphar.2021.683296. eCollection 2021. Authors Chang Chen 1 2 , Yi Zhang 3 4 , Jianying Huang 1 5 , Ping Yin 6 , Zhenshun Cheng 7 , Jianyuan Wu 1 5 , Song Chen 8 , Yongxi Zhang 9 , Bo Chen 1 5 , Mengxin Lu 8 , Yongwen Luo 8 , Lingao Ju 8 , Jingyi Zhang 10 , Xinghuan Wang 1 5 8 11 Affiliations 1 Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, China. 2 Department of Anesthesiology, Zhongnan Hospital of Wuhan University, Wuhan, China. 3 Center for Life Sciences, Peking University, Beijing, China. 4 Euler Technology, Beijing, China. 5 Wuhan Leishenshan Hospital, Wuhan, China. 6 Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 7 Department of Respiratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China. 8 Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China. 9 Department of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China. 10 Department of Cardiology, The Third People's Hospital of Hubei Province, Wuhan, China. 11 Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China. Item in Clipboard CiteDisplay options Display options Format Abstract Background: In addition to supportive therapy, antiviral therapy is an effective treatment for coronavirus disease 2019 (COVID-19). 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 AOT or NMV/MV rate (both p > 0.05). The most frequently observed favipiravir-associated adverse event was increased serum uric acid (16/116, OR: 5.52, p = 0.0014). Conclusion: Among patients with COVID-19, favipiravir, compared to Arbidol, did not significantly improve the clinical recovery rate at day 7. Favipiravir significantly improved the latency to relieve pyrexia and cough. Adverse effects caused by favipiravir are mild and manageable. Keywords: COVID-19; SARS-CoV-2; favipiravir; randomized controlled trial; umifenovir (arbidol). Copyright © 2021 Chen, Zhang, Huang, Yin, Cheng, Wu, Chen, Zhang, Chen, Lu, Luo, Ju, Zhang and Wang. Conflict of interest statement Author YZ is employed by the company Euler Technology. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

参考サイト PubMed: covid-19



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