A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications
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 (13 to 17 years), adult (18 to 65 years), and elderly (greater than [>] 65 but less than or equal to [<=] 85 years) non-hospitalized participants with influenza A infection who are at risk of developing complications. The study will be conducted in 3 phases: screening phase, double-blind treatment period (5 days), a post treatment follow-up period (23 days). Study evaluations include efficacy, clinical and virological outcomes, pharmacokinetics (PK), PK/pharmacodynamics, biomarkers, safety and tolerability. The duration of participation in the study for each participant is 28 days.
Inclusion Criteria:
Exclusion Criteria:
Ciudad de Buenos Aires, 1431, Argentina
La Plata Lpl Lpl, 1900, Argentina
Passo Fundo, 99010-080, Brazil
Porto Alegre, 90610-000, Brazil
Viña, Chile
La Roche S/ Yon Cedex 9, 85925, France
Budapest, 1122, Hungary
Cheras Baru, 56100, Malaysia
Culiacán, 80230, Mexico
Pahucha, 42070, Mexico
Specjalistyczna W Brzegu Dolnym, 58 120, Poland
Saint Petersburg, 197376, Russia
KwaZulu-Natal, 4170, South Africa
Van Der Bijl, 1911, South Africa
Gangwon-do, 220-701, South Korea
Muang, 40002, Thailand
Wattana, 10110, Thailand
Poltava, 36000, Ukraine