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. 2020 Mar 18.
doi: 10.1016/j.eng.2020.03.007. Online ahead of print.

Experimental Treatment With Favipiravir for COVID-19: An Open-Label Control Study

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Free PMC article

Experimental Treatment With Favipiravir for COVID-19: An Open-Label Control Study

Qingxian Cai et al. Engineering (Beijing). .
Free PMC article

Abstract

An outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its caused coronavirus disease 2019 (COVID-19) has been reported in China since December 2019. More than 16% of patients developed acute respiratory distress syndrome, and the fatality ratio was about 1%-2%. No specific treatment has been reported. Herein, we examine 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)-α by aerosol inhalation (5 million U 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-α by aerosol inhalation (5 million U 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 time was found for the FPV arm versus the control arm (median (interquartile range, IQR), 4 (2.5-9) d versus 11 (8-13) d, P < 0.001). The FPV arm also showed significant improvement in chest imaging 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 imaging. Multivariable Cox regression showed that FPV was independently associated with faster viral clearance. In addition, fewer adverse reactions were found in the FPV arm than in the control arm. In this open-label nonrandomized control study, FPV showed significantly better treatment effects on COVID-19 in terms of disease progression and viral clearance; if causal, these results should be important information for establishing standard treatment guidelines to combat the SARS-CoV-2 infection.

Keywords: Antiviral therapy; COVID-19; Favipiravir; Open-label nonrandomized control study; SARS-CoV-2.

Figures

Fig. 1
Fig. 1
Score of chest CT scan for a 56-year-old female patient with COVID-19 from the FPV arm. (a–c) show parts of the CT images obtained prior to the FPV treatment, which were scored as 15 according to the scoring method. (d–f) show parts of the CT images obtained on Day 12 after the FPV treatment, which were scored as 6.
Fig. 2
Fig. 2
Flowchart for the present trial. (FPV: LPV/RTV).
Fig. 3
Fig. 3
Kaplan-Meier survival curves for the length of time until viral clearance for both kinds of antiviral therapy (P < 0.001).
Fig. 4
Fig. 4
Time of viral shedding and improving chest CT scan on Day 14 after treatment.

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