COVID-19 Evidence Alerts
from McMaster PLUSTM

Current best evidence for clinical care (more info)

Treatment Udwadia ZF, Singh P, Barkate H, et al. 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. Int J Infect Dis. 2020 Nov 16;103:62-71. doi: 10.1016/j.ijid.2020.11.142.

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.

Discipline / Specialty Area Score
Hospital Doctor/Hospitalists
Internal Medicine
Comments from MORE raters

Hospital Doctor/Hospitalists rater

Larger trials are needed to verify the beneficial signal in the treatment arm.

Hospital Doctor/Hospitalists rater

This is a open label, randomized, in mild, including asymptomatic, to moderate CoVID-19 patients. They use Intent to treat, report CONSORT diagram, in Asian patients, 60% with mild disease, 26% with medical comorbidities. The time of oral shedding of SARS-CoV-2, in both groups is similar. The time to clinical cure of symptomatic patients, 3 days vs 5 days, but the time to use oxygen was 5 vs 2 days, and the time to hospital discharge was 9 vs 10 days. The best results in the moderate COVID patients was in the favipiravir group, 3 days vs 6 days, with similar mortality. The limitations are the small population, open label design and conflict of interest. It’s oral so it can be given at home, in selected Asian population with moderate severity.

Internal Medicine rater

This may be more interesting with more power... so far doesn't look worth giving.