LAST UPDATED
June 08, 2026
Clinicaltrials.gov ID
CTSID
OVERVIEW
A Phase 2, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Obeldesivir in Participants From Birth to < 5 Years of Age With Respiratory Syncytial Virus (RSV) Infection
PROTOCOL SUMMARY
The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve. The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediatric participants with RSV infection; b) To evaluate the efficacy of ODV on time to alleviation of targeted RSV symptoms in pediatric participants with RSV infection.
View moreParticipation requirements
Age
0 - 5 years
Sex
All
Healthy Volunteers
No
Age
0 - 5 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
RSV Infection
Gender
N/A
Date
March 2025 - April 2025
Study Type
Interventional
Study Phase
Phase 2
Product
Obeldesivir, Obeldesivir Placebo
Eligibility information
Inclusion criteria
- Participants assigned male or female at birth, from birth to < 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:
- Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 3 kg to < 40 kg (Part A) and ≥ 1.5 kg to < 3 kg (Part B)
- Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to < 6 kg
- RSV infection diagnosis ≤ 3 days prior to randomization.
- Negative test for influenza A/B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection) ≤ 7 days prior to randomization.
- Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
- Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.
Exclusion criteria
- Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
- Not expected to survive the current RSV-related illness.
- Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
- Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), ≤ 7 days prior to randomization.
- History of asthma or recurrent wheezing.
- Neuromuscular disease that affects swallowing.
- Cystic fibrosis.
- Participants who are immunocompromised.
- Alanine aminotransferase ≥ 5 × upper limit of normal (ULN).
- Abnormal renal function.
- Concurrent or previous treatment with other agents with actual or possible direct antiviral activity against RSV, received within 28 days or within 5 half-lives, whichever is longer, prior to randomization.
- Received palivizumab within 100 days, or nirsevimab within 1 year, or other RSV specific monoclonal antibody within 5 half-lives of the antibody, prior to randomization.
- Participant whose mother received RSV vaccination during pregnancy and who is < 1 year old prior to randomization.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (56)
Cohen Children's Medical Center Pharmacy New Pavillion
Phoenix, Arizona, United States, 11040
Velocity Clinical Research, Phoenix
Phoenix, Arizona, United States, 85015
UCLA (Outpatient Clinic)
Los Angeles, California, United States, 90095
Alliance Research Institute
Lynwood, California, United States, 90262
Paradigm Clinical Research Centers, LLC
San Diego, California, United States, 92108
FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine
Santa Maria, California, United States, 93454
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States, 20016
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States, 30291
Velocity Clinical Research, Sioux City
Sioux City, Iowa, United States, 51106
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, United States, 70508
Velocity Clinical Research - Norfolk
Norfolk, Nebraska, United States, 68701
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States, 68134
Child Health Care Associates
Syracuse, New York, United States, 13210
Epic Medical Research -Oklahoma
Chickasha, Oklahoma, United States, 73018
Central Texas Medical Research, LLC
San Antonio, Texas, United States, 78232
North Houston Internal Medicine and Pediatric Clinic
Tomball, Texas, United States, 77375
Japan Community Healthcare Organization Kyushu Hospital
Fkitakyushu, Japan, 806-0034
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, Japan,
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