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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
RSV Infection
Intervention / Treatment

-

Contacts and Locations

Phoenix

Velocity Clinical Research, Phoenix, Phoenix, Arizona, United States, 85015

Santa Maria

FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine, Santa Maria, California, United States, 93454

Washington

Velocity Clinical Research, Washington DC, Washington, District of Columbia, United States, 20016

Tampa

PAS Research, Tampa, Florida, United States, 33613

Macon

Velocity Clinical Research, Primary Pediatrics, Macon, Macon, Georgia, United States, 31210

Union City

Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia, United States, 30291

Sioux City

Velocity Clinical Research, Sioux City, Sioux City, Iowa, United States, 51106

Lafayette

Velocity Clinical Research, Lafayette, Lafayette, Louisiana, United States, 70508

Great Falls

Boeson Research, Great Falls, Montana, United States, 59405

Norfolk

Velocity Clinical Research - Norfolk, Norfolk, Nebraska, United States, 68701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

to 5 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2026-04