Z. Udwadia, Pawan Singh, H. Barkate, S. Patil, Shabbir Rangwala, Amol Pendse, Jatin Kadam, W. Wu, C. Caracta, M. Tandon
International Journal of Infectious Diseases, 2020
Objective To assess efficacy and safety of favipiravir in adults with mild-to-moderate 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; Days 2-14: 800 mg BID) plus standard supportive care versus supportive care alone. The primary endpoint was time to cessation of viral shedding; time to clinical cure also was measured. Results From May 14-July 3, 2020, 150 patients were randomized to favipiravir (n = 75) or control (n = 75). Median time to 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 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.
Cited by 45 publications.
Field of study: Medicine