Efficacy and safety of favipiravir, an oral RNA-dependent RNA polymerase inhibitor, in mild-to-moderate COVID-19: A randomized, comparative, open-label, multicenter, phase 3 clinical trial

Abstract

Highlights Favipiravir is an oral RNA-dependent RNA polymerase inhibitor. Favipiravir is under investigation in many countries for treatment of COVID-19. We evaluated favipiravir’s efficacy and safety in mild-to-moderate COVID-19. Favipiravir treatment led to significant improvement in time to clinical cure. Favipiravir may be a safe and effective treatment in mild-to-moderate COVID-19.

Favipiravir in Therapy of Viral Infections

“…To assess the efficacy and safety of favipiravir in adults with mild-to-moderate coronavirus disease, Udwadia et al [ 28 ] conducted a randomized, comparative, open-labeled, phase 3 clinical trial. This study included 150 adults (18–75 years) with RT-PCR confirmed COVID-19 and mild-to-moderate symptoms (including asymptomatic) ( Table 1 ), plus standard supportive care ( n = 75) versus supportive care alone ( n = 75).…”

Clinical efficacy and safety of favipiravir in the treatment of COVID-19 patients

“…conducted in China 3 , 4 , 6 and one each in Russia 2 and Oman. 5 The comparator varied, including lopinavir/ritonavir, 3 umifenovir, 6 hydroxychloroquine, 5 baloxavir 4 and standard of care. 2 , 4 First, the pooled analysis of five studies [2][3][4][5][6] showed that favipiravir was associated with a higher clinical improvement rate than control group, but the difference did not reach statistical significance (odds ratio [OR], 1.54; 95% CI, 0.78-3.04; I 2 = 43%, Fig.…”

“… [1] However, the efficacy of favipiravir for treating COVID-19 remained unclear and was not assessed in this study. In fact, several clinical studies [2] , [3] , [4] , [5] , [6] investigating the usefulness of favipiravir for COVID-19 patients have been published and provides us the opportunity to re- assess the clinical efficacy and safety of favipiravir. Therefore, we did a meta-analysis of these clinical studies to provide an update data to clarify this issue –the clinical efficacy and safety of favipiravir in the treatment of COVID-19 patients.…”

“…Overall, five clinical studies [2] , [3] , [4] , [5] , [6] fulfilled the inclusion criteria and were included in this meta-analysis. A total of 552 patients were enrolled in this study, including 252 and 300 patients received favipiravir and comparator, respectively.…”

“…Except Cai et al's study was before-after controlled trial, [3] all the other were randomized controlled trials. [ 2 , [4] , [5] , [6] ] Three studies [3] , [4] , [5] was conducted in a single center and two were multicenter studies. [ 2 , 6 ] Three studies were conducted in China [ 3 , 4 , 6 ] and one each in Russia [2] and Oman.…”