Sapphire 63623872FLZ3001 Influenza A
Research type
Research Study
Full title
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
IRAS ID
259150
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2017-002156-84
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 3 days
Research summary
Influenza A (one of the main types of ‘flu’) causes significant illness and death around the world. Vaccines only provide partial protection so influenza A is still a large problem within the general population. The purpose of this study is to see if pimodivir (the study drug) in combination with the standard treatment is useful for treating patients who have been hospitalised with influenza A. The safety of pimodivir will also be studied. The study is designed so that participants will either receive pimodivir or placebo (non-active) along with standard treatment. This will be assigned at random and neither the study doctor nor participant will know which treatment they are receiving. The study is split into 3 parts: Screening, where baseline measurements and tests will be undertaken; Treatment where the participant will receive the ‘study treatment’ for 5 days, with an option for a 5 day extension for more severe cases; and Follow-up which will involve 5 visits to assess efficacy and safety. Participants will be recruited to the following age groups: adolescents (13 to 15 years), adults (16 to 65 years) and elderly (>65 to <85 years).
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0149
Date of REC Opinion
2 Sep 2019
REC opinion
Further Information Favourable Opinion