NCT02008344

Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,161 (actual)
• Sponsor: MDVI, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

Detailed description

The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects with uncomplicated influenza compared to no treatment (e.g. placebo).

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	favipiravir	Administered twice daily over 5 consecutive days for a total of 10 doses. * Day 1: 1800 mg twice daily (loading doses) * Days 2 through 5: 800 mg twice daily
DRUG	placebo	Administered twice daily over 5 consecutive days for a total of 10 doses. * Day 1: 1800 mg twice daily (loading doses) * Days 2 through 5: 800 mg twice daily

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-12-11
• Last updated: 2015-11-11

Locations

247 sites across 11 countries: United States, Argentina, Brazil, Canada, Colombia, Dominican Republic, El Salvador, Guatemala, Mexico, Peru, Puerto Rico