Abstract
Objective: To assess the efficacy and safety of favipiravir in adults with mild-to-moderate coronavirus disease 2019 (COVID-19).
Methods: 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.
Results: 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.
Conclusion: 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.
Keywords: Antiviral; COVID-19; Coronavirus; Favipiravir; Randomized clinical trial; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, randomized clinical trial, coronavirus, Antiviral, Favipiravir, 【초록키워드】 coronavirus disease, Open-label, viral shedding, Symptom, RT-PCR, Randomized, Asymptomatic, phase 3 trial, Patient, Efficacy and safety, multicenter, disease, RT-PCR assay, supportive care, primary endpoint, Mild-to-moderate, Adverse, median time, statistical significance, worsening, control patients, limitation, standard supportive care, event, lack, died, Significant, 1:1, the primary endpoint, 【제목키워드】 clinical trial, Open-label, Randomized, RNA-dependent RNA polymerase, multicenter, inhibitor, Phase 3, Mild-to-moderate,