Conditions: Influenza
Keywords: Influenza
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 530
Healthy volunteers: no

Brief 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.

Detailed description:
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by 400 mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1 day, followed by 800 mg favipiravir BID for 4 days).

Arms:
arm 1: Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days arm 2: High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days arm 3: Placebo

Interventions: intervention 1: Favipiravir intervention 2: Favipiravir intervention 3: Placebo comparator
Intervention descriptions: intervention 1: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days intervention 2: High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days intervention 3: Placebo BID x 1 day, and Placebo BID x 4 days

Protocol document: