Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study
Comparison of 35 FPV patients and 35 LPV/RTV patients, showing significant improvements in chest CT and faster viral clearance with FPV.
risk of no improvement in CT, 68.7% lower, OR 0.31, p = 0.04, treatment 35, control 45, inverted to make OR<1 favor treatment, multivariate, RR approximated with OR.
risk of no viral clearance, 70.9% lower, HR 0.29, p = 0.03, treatment 35, control 45, inverted to make HR<1 favor treatment, multivariate.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cai et al., 18 Mar 2020, retrospective, China, peer-reviewed, 26 authors.
Abstract: Engineering 6 (2020) 1192–1198
Contents lists available at ScienceDirect
journal homepage: www.elsevier.com/locate/eng
Coronavirus Disease 2019—Article
Experimental Treatment with Favipiravir for COVID-19: An Open-Label
Control Study q
Qingxian Cai a,#, Minghui Yang a,#, Dongjing Liu a,#, Jun Chen a,#, Dan Shu a, Junxia Xia a, Xuejiao Liao a,
Yuanbo Gu a, Qiue Cai a, Yang Yang a, Chenguang Shen a, Xiaohe Li a, Ling Peng a, Deliang Huang a,
Jing Zhang a, Shurong Zhang a, Fuxiang Wang a, Jiaye Liu a, Li Chen a, Shuyan Chen a, Zhaoqin Wang a,
Zheng Zhang a, Ruiyuan Cao b, Wu Zhong b,⇑, Yingxia Liu a,⇑, Lei Liu a,⇑
National Clinical Research Center for Infectious Diseases, The Third People’s Hospital of Shenzhen, The Second Affiliated Hospital of Southern University of Science and
Technology, Shenzhen 518100, China
National Engineering Research Center for the Emergence Drugs, Beijing Institute of Pharmacology and Toxicology, Beijing 100850, China
a r t i c l e
i n f o
Received 7 March 2020
Revised 11 March 2020
Accepted 12 March 2020
Available online 18 March 2020
Open-label nonrandomized control study
a b s t r a c t
There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has been
named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes has been
named coronavirus disease 2019 (COVID-19). More than 16% of patients developed acute respiratory distress syndrome, and the fatality ratio was 1%–2%. No specific treatment has been reported. Herein, we
examined the effects of favipiravir (FPV) versus lopinavir (LPV)/ritonavir (RTV) for the treatment of
COVID-19. Patients with laboratory-confirmed COVID-19 who received oral FPV (Day 1: 1600 mg twice
daily; Days 2–14: 600 mg twice daily) plus interferon (IFN)-a by aerosol inhalation (5 million international unit (IU) twice daily) were included in the FPV arm of this study, whereas patients who were treated with LPV/RTV (Days 1–14: 400 mg/100 mg twice daily) plus IFN-a by aerosol inhalation (5 million IU
twice daily) were included in the control arm. Changes in chest computed tomography (CT), viral clearance, and drug safety were compared between the two groups. For the 35 patients enrolled in the FPV
arm and the 45 patients in the control arm, all baseline characteristics were comparable between the
two arms. A shorter viral clearance median time was found for the FPV arm versus the control arm
(4 d (interquartile range (IQR): 2.5–9) versus 11 d (IQR: 8–13), P < 0.001). The FPV arm also showed significant improvement in chest CT compared with the control arm, with an improvement rate of 91.43%
versus 62.22% (P = 0.004). After adjustment for potential confounders, the FPV arm also showed a
significantly higher improvement rate in chest CT. Multivariable Cox regression showed that FPV was
independently associated with faster viral clearance. In addition, fewer adverse events were found in
the FPV arm than in the control arm. In this open-label before-after controlled study, FPV showed
better therapeutic responses on COVID-19 in terms of disease progression and viral clearance. These
preliminary clinical results provide useful information of treatments for SARS-CoV-2 infection.
Ó 2020 THE AUTHORS. Published by Elsevier LTD on behalf of Chinese Academy of Engineering and
Higher Education Press Limited Company. This is..
is less effective
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