August 4, 2020

Interim Results of a Phase II/III Multicenter Randomized Clinical Trial of AVIFAVIR in Hospitalized Patients with COVID-19

Category: Article Summary

Topic: Testing and Treatment

• [pre–print, not peer-reviewed] Ivashchenko et al. report on a phase II/III randomized clinical trial of the antiviral agent favipiravir. Hospitalized patients with pneumonia and confirmed SARS-CoV-2 infection (n=60) were randomized in a 1:1:1 ratio to receive low-dose favipiravir, high-dose favipiravir, or standard of care (SOC). Patients receiving favipiravir (both arms combined) were more likely than patients in SOC arm to have viral clearance by day 5 (63% vs 30%) and have lower median time to fever resolution (2 vs 4 days). Improvements in chest CT scans by day 15 was similar (83% favipiravir arms vs 75% SOC). However, at the time of the interim analysis, more patients in the SOC arm (90%) versus the favipiravir arm (80%) had been discharged. Mild to moderate adverse drug reactions were reported in 18% of patients, resulting in 5% early discontinuation. Efficacy and safety results were similar for both (high- and low-dose) favipiravir arms.  

Ivashchenko et al. (August 4, 2020). Interim Results of a Phase II/III Multicenter Randomized Clinical Trial of AVIFAVIR in Hospitalized Patients with COVID-19. Pre-print downloaded on August 4 from https://doi.org/10.1101/2020.07.26.20154724