• Favipiravir is an oral RNA-dependent RNA polymerase inhibitor • Favipiravir is under investigation in many countries for the 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 To assess the efficacy and safety of favipiravir in adults with mild-to-moderate coronavirus disease 2019 (COVID-19) In this randomized, open-label, parallel-arm, multicenter, phase 3 trial, adults (18–75 years) with RT-PCR confirmed COVID-19 and mild-to-moderate symptoms (including asymptomatic) were randomized 1:1 to oral favipiravir (day 1 : 1800 mg BID and days 2−14 : 800 mg BID) plus standard supportive care versus supportive care alone The primary endpoint was time to the cessation of viral shedding; time to clinical cure was also measured From May 14 to July 3 , 2020 , 150 patients were randomized to favipiravir (n = 75) or control (n = 75) Median time to the cessation of viral shedding was 5 days (95% CI : 4 days , 7 days) versus 7 days (95% CI : 5 days , 8 days), P = 0 129, and median time to clinical cure was 3 days (95% CI : 3 days , 4 days) versus 5 days (95% CI : 4 days , 6 days), P = 0 030, for favipiravir and control, respectively Adverse events were observed in 36% of favipiravir and 8% of control patients One control patient died due to worsening disease The lack of statistical significance on the primary endpoint was confounded by limitations of the RT-PCR assay Significant improvement in time to clinical cure suggests favipiravir may be beneficial in mild-to-moderate COVID-19 [ABSTRACT FROM AUTHOR]

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