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NCT06784973

PHASE2

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - 5 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-03-05

Completion Date

2025-04-16

Last Updated

2026-06-08

Healthy Volunteers

Conditions

RSV Infection

Interventions

DRUG

Obeldesivir

Administered orally

DRUG

Obeldesivir Placebo

Administered orally

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 ≥ 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. Key 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 (56)

Children's of Alabama

Birmingham, Alabama, United States

Midway Medical Clinic

Oneonta, Alabama, United States

Cohen Children's Medical Center Pharmacy New Pavillion

Phoenix, Arizona, United States

Velocity Clinical Research, Phoenix

Phoenix, Arizona, United States

UCLA (Outpatient Clinic)

Los Angeles, California, United States

Alliance Research Institute

Lynwood, California, United States

Paradigm Clinical Research

Modesto, California, United States

Paradigm Clinical Research Centers, LLC

San Diego, California, United States

FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine

Santa Maria, California, United States

Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia, United States

Dolphin Medical Research

Doral, Florida, United States

Nona Pediatric Center

Orlando, Florida, United States

PAS Research

Tampa, Florida, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Velocity Clinical Research, Sioux City

Sioux City, Iowa, United States

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, United States

Boeson Research

Great Falls, Montana, United States

Boeson Research

Kalispell, Montana, United States

Boeson Research

Missoula, Montana, United States

Velocity Clinical Research - Norfolk

Norfolk, Nebraska, United States

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

Child Health Care Associates

Syracuse, New York, United States

Epic Medical Research -Oklahoma

Chickasha, Oklahoma, United States

Tekton Research, LLC

Yukon, Oklahoma, United States

PAS Research

Pittsburgh, Pennsylvania, United States

Helios Clinical Research

Burleson, Texas, United States

Epic Medical Research - DeSoto

DeSoto, Texas, United States

PAS Research

Edinburg, Texas, United States

Helios Clinical Research

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Sunrise Pediatrics

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Pioneer Research Solutions Inc.

Houston, Texas, United States

Radiance Clinical Research

Lampasas, Texas, United States

Pediatric Center

Richmond, Texas, United States

Central Texas Medical Research, LLC

San Antonio, Texas, United States

North Houston Internal Medicine and Pediatric Clinic

Tomball, Texas, United States

Tanner Clinic

Kaysville, Utah, United States

Tanner Clinic

Layton, Utah, United States

Boeson Research PVU

Provo, Utah, United States

Yoshimura Child Clinic

Akashi, Japan

Japan Community Healthcare Organization Kyushu Hospital

Fkitakyushu, Japan

Uchida child clinic

Fukuoka, Japan

Shindo Children's Clinic

Fukuoka, Japan

SEKI Children's CLINIC

Fukuoka, Japan

Ryuseidai Children's Clinic

Ibaraki, Japan

Isesaki Municipal Hospital

Isesaki, Japan

Abe Child Clinic

Kanagawa, Japan

Okada Kodomonomori Clinic

Kasukabe, Japan

Yutaka Children Clinic

Kobe, Japan

Kochi Health Sciences Center

Kochi, Japan

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, Japan

Shimamura Memorial Hospital

Nerima-ku, Japan

Shizuoka Welfare Hospital

Shizuoka, Japan

Shizuoka City Shimizu Hospital

Shizuoka, Japan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)