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STATUS Terminated

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

See if your child qualifies OR Call 1-833-GIL-EAD-6
See if your child qualifies OR Call 1-833-GIL-EAD-6

LAST UPDATED

June 25 2025

Clinicaltrials.gov ID

NCT06784973

CTSID

2024-517998-24

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.

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Participation Requirements

Calendar

Age

0 - 5 Years

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

RSV Infection

Gender

N/A

Date

March 2025 - April 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Obeldesivir, Obeldesivir Placebo

Eligibility Information

Inclusion

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.
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Exclusion

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.
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Locations

Locations (56)
Other

Children's of Alabama

Birmingham, Alabama, United States, 35233

Other

Midway Medical Clinic

Oneonta, Alabama, United States, 35121

Other

Cohen Children's Medical Center Pharmacy New Pavillion

Phoenix, Arizona, United States, 11040

Other

Velocity Clinical Research, Phoenix

Phoenix, Arizona, United States, 85015

Other

UCLA (Outpatient Clinic)

Los Angeles, California, United States, 90095

Other

Alliance Research Institute

Lynwood, California, United States, 90262

Other

Paradigm Clinical Research

Modesto, California, United States, 95355

Other

Paradigm Clinical Research Centers, LLC

San Diego, California, United States, 92108

Other

FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine

Santa Maria, California, United States, 93454

Other

Velocity Clinical Research, Washington DC

Washington, District of Columbia, United States, 20016

Other

Dolphin Medical Research

Doral, Florida, United States, 33172

Other

Nona Pediatric Center

Orlando, Florida, United States, 32829

Other

PAS Research

Tampa, Florida, United States, 33613

Other

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States, 30291

Other

Clinical Research Prime

Idaho Falls, Idaho, United States, 83404

Other

Velocity Clinical Research, Sioux City

Sioux City, Iowa, United States, 51106

Other

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, United States, 70508

Other

Boeson Research

Great Falls, Montana, United States, 59405

Other

Boeson Research

Kalispell, Montana, United States, 59901

Other

Boeson Research

Missoula, Montana, United States, 59804

Other

Velocity Clinical Research - Norfolk

Norfolk, Nebraska, United States, 68701

Other

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States, 68134

Other

Child Health Care Associates

Syracuse, New York, United States, 13210

Other

Epic Medical Research -Oklahoma

Chickasha, Oklahoma, United States, 73018

Other

Tekton Research, LLC

Yukon, Oklahoma, United States, 73099

Other

PAS Research

Pittsburgh, Pennsylvania, United States, 15227

Other

Helios Clinical Research

Burleson, Texas, United States, 76028

Other

Epic Medical Research - DeSoto

DeSoto, Texas, United States, 75115

Other

PAS Research

Edinburg, Texas, United States, 78539

Other

Helios Clinical Research

Houston, Texas, United States, 77008

Other

Biopharma Informatic, LLC

Houston, Texas, United States, 77043

Other

Sunrise Pediatrics

Houston, Texas, United States, 77077

Other

Biopharma Informatic, LLC

Houston, Texas, United States, 77084

Other

Pioneer Research Solutions Inc.

Houston, Texas, United States, 77099

Other

Radiance Clinical Research

Lampasas, Texas, United States, 76550

Other

Pediatric Center

Richmond, Texas, United States, 77469

Other

Central Texas Medical Research, LLC

San Antonio, Texas, United States, 78232

Other

North Houston Internal Medicine and Pediatric Clinic

Tomball, Texas, United States, 77375

Other

Tanner Clinic

Kaysville, Utah, United States, 84037

Other

Tanner Clinic

Layton, Utah, United States, 84041

Other

Boeson Research PVU

Provo, Utah, United States, 84604

Other

Yoshimura Child Clinic

Akashi, Japan, 674-0068

Other

Japan Community Healthcare Organization Kyushu Hospital

Fkitakyushu, Japan, 806-0034

Other

Uchida child clinic

Fukuoka, Japan, 814-0104

Other

Shindo Children's Clinic

Fukuoka, Japan, 814-0121

Other

SEKI Children's CLINIC

Fukuoka, Japan, 814-0123

Other

Ryuseidai Children's Clinic

Ibaraki, Japan, 305-0008

Other

Isesaki Municipal Hospital

Isesaki, Japan, 372-0817

Other

Abe Child Clinic

Kanagawa, Japan, 223-0051

Other

Okada Kodomonomori Clinic

Kasukabe, Japan, 344-0011

Other

Yutaka Children Clinic

Kobe, Japan, 651-2273

Other

Kochi Health Sciences Center

Kochi, Japan, 781-8555

Other

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, Japan

Other

Shimamura Memorial Hospital

Nerima-ku, Japan, 177-0051

Other

Shizuoka Welfare Hospital

Shizuoka, Japan, 420-0005

Other

Shizuoka City Shimizu Hospital

Shizuoka, Japan, 424-8636