Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19

COVID-19 Clinical Trial

Official title: Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir Compared to Standard of Care in Hospitalized Subjects With COVID-19

Status Completed

Clinical Trial Summary

To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.

Clinical Trial Description

This is an open label, randomized, controlled, multicenter Phase 2 proof-of-concept study of favipiravir in hospitalized subjects with Corona Virus Disease (COVID) -19. Subjects will be randomized within their study site and stratified by the severity of their disease to receive either favipiravir + standard of care (SOC) or SOC alone.

The dose regimen will be 1800 mg favipiravir bis in die (BID) plus SOC or SOC alone on Day 1 followed by 1000 mg BID favipiravir (800 mg BID for subjects with Child-Pugh A liver impairment) plus SOC or SOC for the next 13 days.

The study will have 14 days of treatment and 46 days of follow-up.

Approximately 50 patients are planned to be enrolled in the trial at approximately 8 study sites in the US. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04358549
• Study type: Interventional
• Source: Fujifilm Pharmaceuticals U.S.A., Inc.
• Status: Completed
• Phase: Phase 2
• Start date: April 17, 2020
• Completion date: October 30, 2020