TERMINATED

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-03-05
Study Completion:2025-04-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06784973

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.

Ages Eligible for Study:Not specified to 5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to \< 40 kg
  3. * Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to \< 6 kg
  4. * RSV infection diagnosis ≤ 3 days prior to randomization.
  5. * Negative test for influenza A/B, and SARS-CoV-2 infection ≤ 7 days prior to randomization.
  6. * Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
  7. * Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.
  1. * Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
  2. * Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
  3. * 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.
  4. * History of asthma or recurrent wheezing.
  5. * Neuromuscular disease that affects swallowing.
  6. * Cystic fibrosis.
  7. * Participants who are immunocompromised.
  8. * Alanine aminotransferase ≥ 5 × upper limit of normal (ULN).
  9. * Abnormal renal function.
  10. * 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.
  11. * 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.
  12. * Participant whose mother received RSV vaccination during pregnancy and who is \< 1 year old prior to randomization.

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Children's of Alabama
Birmingham, Alabama, 35233
United States
Midway Medical Clinic
Oneonta, Alabama, 35121
United States
Cohen Children's Medical Center Pharmacy New Pavillion
Phoenix, Arizona, 11040
United States
Velocity Clinical Research, Phoenix
Phoenix, Arizona, 85015
United States
UCLA (Outpatient Clinic)
Los Angeles, California, 90095
United States
Alliance Research Institute
Lynwood, California, 90262
United States
Paradigm Clinical Research
Modesto, California, 95355
United States
Paradigm Clinical Research Centers, LLC
San Diego, California, 92108
United States
FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine
Santa Maria, California, 93454
United States
Velocity Clinical Research, Washington DC
Washington, District of Columbia, 20016
United States
Dolphin Medical Research
Doral, Florida, 33172
United States
Nona Pediatric Center
Orlando, Florida, 32829
United States
PAS Research
Tampa, Florida, 33613
United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
United States
Clinical Research Prime
Idaho Falls, Idaho, 83404
United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106
United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, 70508
United States
Boeson Research
Great Falls, Montana, 59405
United States
Boeson Research
Kalispell, Montana, 59901
United States
Boeson Research
Missoula, Montana, 59804
United States
Velocity Clinical Research - Norfolk
Norfolk, Nebraska, 68701
United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
United States
Child Health Care Associates
Syracuse, New York, 13210
United States
Epic Medical Research -Oklahoma
Chickasha, Oklahoma, 73018
United States
Tekton Research, LLC
Yukon, Oklahoma, 73099
United States
PAS Research
Pittsburgh, Pennsylvania, 15227
United States
Helios Clinical Research
Burleson, Texas, 76028
United States
Epic Medical Research - DeSoto
DeSoto, Texas, 75115
United States
PAS Research
Edinburg, Texas, 78539
United States
Helios Clinical Research
Houston, Texas, 77008
United States
Biopharma Informatic, LLC
Houston, Texas, 77043
United States
Sunrise Pediatrics
Houston, Texas, 77077
United States
Biopharma Informatic, LLC
Houston, Texas, 77084
United States
Pioneer Research Solutions Inc.
Houston, Texas, 77099
United States
Radiance Clinical Research
Lampasas, Texas, 76550
United States
Pediatric Center
Richmond, Texas, 77469
United States
Central Texas Medical Research, LLC
San Antonio, Texas, 78232
United States
North Houston Internal Medicine and Pediatric Clinic
Tomball, Texas, 77375
United States
Tanner Clinic
Kaysville, Utah, 84037
United States
Tanner Clinic
Layton, Utah, 84041
United States
Boeson Research PVU
Provo, Utah, 84604
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-05
Study Completion Date2025-04-16

Study Record Updates

Study Start Date2025-03-05
Study Completion Date2025-04-16

Terms related to this study

Additional Relevant MeSH Terms

  • RSV Infection