Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

Phase 2 Completed 530 enrolled MDVI, LLC

RandomizedFactorialQuadruple-blindTreatment

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated influenza.

Timeline

Start: 2010-02
Primary completion: 2012-04
Completion: 2012-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); 1: Low Dose Favipiravir vs 2: High Dose Favipiravir vs Placebo; p = .05; Gehan-Wilcoxon NCT01068912 ↗

Publications

Hayden FG, Lenk RP, Epstein C, Kang LL. Oral Favipiravir Exposure and Pharmacodynamic Effects in Adult Outpatients With Acute Influenza. J Infect Dis. 2024 Aug 16;230(2):e395-e404. doi: 10.1093/infdis/jiad409.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Favipiravir	Small molecule	400 mg	Oral
Subject	Favipiravir	Small molecule	800 mg	Oral