GS-US-218-1797 GS-5806 in Lung Transplant Recipients with RSV
Research type
Research Study
Full title
A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection
IRAS ID
187727
Contact name
Jasvir Parmar
Contact email
Sponsor organisation
Gilead Sciences Inc
Eudract number
2015-002287-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Respiratory syncytial virus (RSV) is a respiratory virus that infects the lungs and breathing passages. Immunosuppressed adults, such as recipients of a lung transplant (LT) are particularly at risk. Each winter, up to 12% of LT patients are infected with RSV resulting in a mortality rate as high as 10% to 20%. There is a significant unmet medical need for a safe, convenient, and effective treatment for RSV infection. Treatment for RSV infection in LT patients is supportive, with use of intravenous hydration, supplemental oxygen, and mechanical ventilation as required.
GS-5806 is an oral RSV fusion inhibitor with potent and selective anti-RSV activity in vitro and has been given to almost 300 adults of whom 245 were healthy adult volunteers; none experienced a serious drug side effect.
The purpose of this study is to look at the effect of GS-5806 on RSV, longer term complication of the RSV infection, lung function and safety and tolerability of GS-5806 in LT patients.
Approximately 60 participants will take part in this study in the UK and other countries. Participation in the main part of the study lasts 28 days, with 8 study related visits (with the option of some home visits). There is an optional extended viral monitoring portion (additional 28 days with 4 additional study related visits) and an optional data registry portion (additional 48 weeks with 3 visits).
All subjects will receive the standard-of-care therapy for RSV infection plus GS-5806 or placebo at a ratio of 2:1. Neither the participants nor the study team will know whether the participant is taking GS-5806 or placebo.
Participants will undergo nasal, blood and urine sampling, physical exams, measurement of vital signs, breathing tests (spirometry) and the completion of questionnaires. There is also a participant diary.
Gilead Sciences Inc. is sponsoring this study.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0599
Date of REC Opinion
24 Nov 2015
REC opinion
Further Information Favourable Opinion