A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
This double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent, adult, and elderly hospitalized participants with influenza A infection. The study will be conducted in 3 phases: screening phase, double-blind treatment period of 5 days (with the possibility to extend treatment period by 5 days for participants who will enter an optional double-blind extension treatment arm), and post treatment follow-up period of 23 days. Study evaluations will include efficacy, pharmacokinetic, biomarkers, safety and tolerability. The duration of participation in study for each participant is 28 days, except for participants receiving extended treatment, for whom study duration will be up to 33 days.
Inclusion Criteria:
Exclusion Criteria:
Kalamazoo, Michigan 49008, United States
C.a.b.a., 1431, Argentina
La Plata Lpl Lpl, 1900, Argentina
Passo Fundo, 99010-080, Brazil
Porto Alegre, 90610-000, Brazil
São José do Rio Preto, 15090-000, Brazil
La Roche S/ Yon Cedex 9, 85925, France
Farkasgyepü, 8582, Hungary
Riga District, LV-2118, Latvia
Vilnius, 08117, Lithuania
Gangwon-do, 220-701, South Korea
Muang, 11000, Thailand
Muang, 40002, Thailand
Wattana, 10110, Thailand
Poltava, 36000, Ukraine