Alliance for Pandemic Preparedness

November 20, 2020

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

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  • In a randomized, multicenter, open-label, parallel-arm, Phase 3 trial of adults in India with non-severe COVID-19 (including asymptomatic patients), those who received the antiviral drug favipavir within seven days of symptoms onset had faster clinical recovery compared to placebo. Median time to clinical cure was 3 days (95%CI: 3-4 days) in those who received oral favipavir versus 5 days (95%CI: 4-6 days) in those who received placebo (p = 0.030). Median time to cessation of viral shedding was 5 days in the favipavir arm (95% CI: 4-7 days) vs 7 days in the placebo arm (95% CI: 5-8 days) (p = 0.129). Of note, the primary endpoint of this trial was viral shedding.

Udwadia et al. (Nov 19, 2020). 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. International Journal of Infectious Diseases. https://doi.org/10.1016/j.ijid.2020.11.142