C5241007 - Phase 2/3 study to investigate Sisunatovir in adults with respiratory syncytial virus
Research type
Research Study
Full title
AN INTERVENTIONAL PHASE 2/3, ADAPTIVE, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ORAL SISUNATOVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULTS WITH RESPIRATORY SYNCYTIAL VIRUS INFECTION WHO ARE AT RISK OF PROGRESSION TO SEVERE ILLNESS
IRAS ID
1008986
Contact name
Margaret Tawadrous
Contact email
Sponsor organisation
Pfizer Inc.
Clinicaltrials.gov Identifier
Research summary
This study will evaluate if an experimental medicine, sisunatovir, helps treating a respiratory infection caused by the respiratory syncytial virus, or RSV.
RSV usually causes mild symptoms such as runny nose, cough, and sore throat, however, in some people with health issues such as lung or heart problem, older age and problems of the immune system, it can cause severe lung infection that require admission to the hospital and can cause death. This study is intended for such people with increased risks.
Each participant will be in the study for approximately 5 weeks. There are a pre-screening and screening visit, where patients with respiratory symptoms are tested for RSV and, if positive, are evaluated to check if they meet the requirements for participation in the study. Once the patient has been enrolled, they will receive treatment with sisunatovir tablets or placebo tablets, at the dose of 200 mg to take twice daily for 5 days. The assignment to active treatment with sisunatovir or placebo is casual and neither the patient nor the study doctor and staff are aware of the assignment.
After the treatment phase, there will be a follow up phase that lasts 4 weeks. The number of visits required is 7, plus a screening visit that can be done on the same day of enrolment or Day 1. The prescreening visit is optional, and it is intended for RSV testing for those patients with symptoms that do not have access to RSV testing as per their routine medical care.
During the study, participants will undertake several assessments and procedures, including blood tests, nasopharyngeal swabs, physical examination, and electrocardiograms.
The primary objective of the study is to evaluate the efficacy of sisunatovir in preventing admissions to the hospital that are caused by RSV and death.REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0049
Date of REC Opinion
20 Feb 2024
REC opinion
Further Information Favourable Opinion