1227 - Phase 2b double-blind study of hospitalised adults with RSV
Research type
Research Study
Full title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults with Respiratory Syncytial Virus (RSV) Infection
IRAS ID
160824
Contact name
Harmesh Moudgil
Contact email
Sponsor organisation
Gilead Sciences Inc
Eudract number
2014-002137-58
Clinicaltrials.gov Identifier
Research summary
Human respiratory syncytial virus (RSV) is a virus that causes respiratory tract infections. It is a major cause of lower respiratory tract infections and hospital visits during infancy and childhood. RSV infection is also a cause of respiratory disease in adult populations. The 2 adult populations that are at higher risk for an RSV infection are the immunocompromised (less capable of battling infections) and the elderly.
Like a cold virus, RSV attacks the nose, eyes, throat, and lungs. It spreads like a cold too, and may be passed to another person through coughing, sneezing, touching contaminated surfaces, or sharing food or drinks. There are many kinds of RSV, and the virus changes over time, so the body will never become immune to it. A person can get it throughout their life, sometimes during the same season. Currently there is an unmet need for a safe, convenient, and effective treatment for RSV.
The purpose of this study is to evaluate safety, antiviral effects, and tolerability of GS-5806 (study drug) in hospitalised adults with RSV in a natural infection setting. Approximately 200 RSV positive patients will participate worldwide.
This is a double-blind study, meaning neither the participant nor their Study Doctor will know what study drug the participant will receive. Participants who provide written consent and meet eligibility criteria will be randomly assigned to GS-5806 or placebo (dummy drug).
The study includes:
Screening - Confirm if participants are suitable.
Baseline – Safety procedures completed, and suitable participants given study drug
Follow up: Participants return for visits on days 2, 3, 5, 7, 14 and 28 (end of study) to track ongoing symptoms and overall health.Study procedures include nasal and/or throat swabs, medical history evaluation, ECG, height, weight, temperature, blood and urine samples, questionnaires, vital signs, adverse event and concomitant (ongoing) medications collection.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/1103
Date of REC Opinion
29 Sep 2014
REC opinion
Further Information Favourable Opinion