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Not recruiting

Phase 2

ObeldesivirStudy of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection

Sponsor:

Gilead Sciences

Code:

NCT06784973

Conditions

RSV Infection

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

Interventions

Obeldesivir

Obeldesivir Placebo

Study Details

Brief 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.

Conditions

RSV Infection

Study ID

NCT06784973

Start date

Mar 5, 2025

Status verified date

May, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

Key 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 ≥ 1.5 kg to < 40 kg
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 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.

Key Exclusion Criteria:

Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Obeldesivir

Participants will receive an age and weight appropriate ODV dose based on their cohort/group assignment.

experimental: Obeldesivir Placebo

Participants will receive an age and weight appropriate ODV placebo dose based on their cohort/group assignment.

Interventions

Obeldesivir

Administered orally

Obeldesivir Placebo

Administered orally

Primary outcome measure

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Through Day 28 [ Time Frame: First dose up to 28 days ]
Percentage of Participants Experiencing Grade 3 or 4 Treatment-emergent laboratory abnormalities by Day 28 [ Time Frame: First dose up to 28 days ]
Time to Alleviation of Targeted RSV Symptoms by Day 28 [ Time Frame: First dose up to 28 days ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Midway Medical Clinic

Recruiting

Oneonta, Alabama, United States, 35121

Cohen Children's Medical Center Pharmacy New Pavillion

Recruiting

Phoenix, Arizona, United States, 11040

Velocity Clinical Research, Phoenix

Recruiting

Phoenix, Arizona, United States, 85015

UCLA (Outpatient Clinic)

Recruiting

Los Angeles, California, United States, 90095

Alliance Research Institute

Recruiting

Lynwood, California, United States, 90262

Paradigm Clinical Research

Recruiting

Modesto, California, United States, 95355

Paradigm Clinical Research Centers, LLC

Recruiting

San Diego, California, United States, 92108

FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine

Recruiting

Santa Maria, California, United States, 93454

Velocity Clinical Research, Washington DC

Recruiting

Washington, District of Columbia, United States, 20016

Dolphin Medical Research

Recruiting

Doral, Florida, United States, 33172

Nona Pediatric Center

Recruiting

Orlando, Florida, United States, 32829

PAS Research

Recruiting

Tampa, Florida, United States, 33613

Rophe Adult and Pediatric Medicine/SKYCRNG

Recruiting

Union City, Georgia, United States, 30291

Clinical Research Prime

Recruiting

Idaho Falls, Idaho, United States, 83404

Velocity Clinical Research, Sioux City

Recruiting

Sioux City, Iowa, United States, 51106

Velocity Clinical Research, Lafayette

Recruiting

Lafayette, Louisiana, United States, 70508

Boeson Research

Recruiting

Great Falls, Montana, United States, 59405

Boeson Research

Recruiting

Kalispell, Montana, United States, 59901

Boeson Research

Recruiting

Missoula, Montana, United States, 59804

Velocity Clinical Research - Norfolk

Recruiting

Norfolk, Nebraska, United States, 68701

Velocity Clinical Research, Omaha

Recruiting

Omaha, Nebraska, United States, 68134

Child Health Care Associates

Recruiting

Syracuse, New York, United States, 13210

Epic Medical Research -Oklahoma

Recruiting

Chickasha, Oklahoma, United States, 73018

Tekton Research, LLC

Recruiting

Yukon, Oklahoma, United States, 73099

PAS Research

Recruiting

Pittsburgh, Pennsylvania, United States, 15227

Helios Clinical Research

Recruiting

Burleson, Texas, United States, 76028

Epic Medical Research - DeSoto

Recruiting

DeSoto, Texas, United States, 75115

PAS Research

Recruiting

Edinburg, Texas, United States, 78539

Helios Clinical Research

Recruiting

Houston, Texas, United States, 77008

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77043

Sunrise Pediatrics

Recruiting

Houston, Texas, United States, 77077

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77084

Pioneer Research Solutions Inc.

Recruiting

Houston, Texas, United States, 77099

Radiance Clinical Research

Recruiting

Lampasas, Texas, United States, 76550

Pediatric Center

Recruiting

Richmond, Texas, United States, 77469

Central Texas Medical Research, LLC

Recruiting

San Antonio, Texas, United States, 78232

North Houston Internal Medicine and Pediatric Clinic

Recruiting

Tomball, Texas, United States, 77375

Tanner Clinic

Recruiting

Kaysville, Utah, United States, 84037

Tanner Clinic

Recruiting

Layton, Utah, United States, 84041

Boeson Research PVU

Recruiting

Provo, Utah, United States, 84604

More Information

Sponsor

Gilead Sciences

Last update posted

May 15, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2025-05-15.