Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (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

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.

Study Overview

• Status: Terminated
• Conditions: RSV Infection
• Intervention / Treatment: Drug: Obeldesivir; Drug: Obeldesivir Placebo

Detailed Description

Pediatric participants will be enrolled as follows:

• 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

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Akashi, Japan, 674-0068
    • Yoshimura Child Clinic
  • Fkitakyushu, Japan, 806-0034
    • Japan Community Healthcare Organization Kyushu Hospital
  • Fukuoka, Japan, 814-0104
    • Uchida child clinic
  • Fukuoka, Japan, 814-0121
    • Shindo Children's Clinic
  • Fukuoka, Japan, 814-0123
    • SEKI Children's CLINIC
  • Ibaraki, Japan, 305-0008
    • Ryuseidai Children's Clinic
  • Isesaki, Japan, 372-0817
    • Isesaki Municipal Hospital
  • Kanagawa, Japan, 223-0051
    • Abe Child Clinic
  • Kasukabe, Japan, 344-0011
    • Okada Kodomonomori Clinic
  • Kobe, Japan, 651-2273
    • Yutaka Children Clinic
  • Kochi, Japan, 781-8555
    • Kochi Health Sciences Center
  • Nagoya, Japan
    • Japan Community Healthcare Organization Chukyo Hospital
  • Nerima-ku, Japan, 177-0051
    • Shimamura Memorial Hospital
  • Shizuoka, Japan, 424-8636
    • Shizuoka City Shimizu Hospital
  • Shizuoka, Japan, 420-0005
    • Shizuoka Welfare Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's of Alabama
    • Oneonta, Alabama, United States, 35121
      • Midway Medical Clinic
  • Arizona
    • Phoenix, Arizona, United States, 11040
      • Cohen Children's Medical Center Pharmacy New Pavillion
    • Phoenix, Arizona, United States, 85015
      • Velocity Clinical Research, Phoenix
  • California
    • Los Angeles, California, United States, 90095
      • UCLA (outpatient clinic)
    • Lynwood, California, United States, 90262
      • Alliance Research Institute
    • Modesto, California, United States, 95355
      • Paradigm Clinical Research
    • San Diego, California, United States, 92108
      • Paradigm Clinical Research Centers, LLC
    • Santa Maria, California, United States, 93454
      • FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Velocity Clinical Research, Washington DC
  • Florida
    • Doral, Florida, United States, 33172
      • Dolphin Medical Research
    • Orlando, Florida, United States, 32829
      • Nona Pediatric Center
    • Tampa, Florida, United States, 33613
      • PAS Research
  • Georgia
    • Union City, Georgia, United States, 30291
      • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Velocity Clinical Research, Sioux City
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research, Lafayette
  • Montana
    • Great Falls, Montana, United States, 59405
      • Boeson Research
    • Kalispell, Montana, United States, 59901
      • Boeson Research
    • Missoula, Montana, United States, 59804
      • Boeson Research
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Velocity Clinical Research - Norfolk
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha
  • New York
    • Syracuse, New York, United States, 13210
      • Child Health Care Associates
  • Oklahoma
    • Chickasha, Oklahoma, United States, 73018
      • Epic Medical Research -Oklahoma
    • Yukon, Oklahoma, United States, 73099
      • Tekton Research, LLC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15227
      • PAS Research
  • Texas
    • Burleson, Texas, United States, 76028
      • Helios Clinical Research
    • DeSoto, Texas, United States, 75115
      • Epic Medical Research - DeSoto
    • Edinburg, Texas, United States, 78539
      • PAS Research
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions Inc.
    • Houston, Texas, United States, 77008
      • Helios Clinical Research
    • Houston, Texas, United States, 77077
      • Sunrise Pediatrics
    • Lampasas, Texas, United States, 76550
      • Radiance Clinical Research
    • Richmond, Texas, United States, 77469
      • Pediatric Center
    • San Antonio, Texas, United States, 78232
      • Central Texas Medical Research, LLC
    • Tomball, Texas, United States, 77375
      • North Houston Internal Medicine and Pediatric Clinic
  • Utah
    • Kaysville, Utah, United States, 84037
      • Tanner Clinic
    • Layton, Utah, United States, 84041
      • Tanner Clinic
    • Provo, Utah, United States, 84604
      • Boeson Research PVU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obeldesivir; Participants will receive an age and weight appropriate ODV dose based on their cohort/group assignment.	Drug: Obeldesivir; Administered orally; Other Names: GS-5245; ODV
Experimental: Obeldesivir Placebo; Participants will receive an age and weight appropriate ODV placebo dose based on their cohort/group assignment.	Drug: Obeldesivir Placebo; Administered orally

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) parameter AUCtau of ODV metabolite, GS-441524	AUCtau is defined as the area under the concentration versus time curve over the dosing interval.	Day 1 to Day 5
PK parameter Cmax of ODV metabolite, GS-441524	Cmax is defined as the concentration at the end of the dosing interval.	Day 1 to Day 5
PK parameter Ctrough of ODV metabolite, GS-441524	Ctrough is defined as the concentration at the endo of the dosing interval.	Day 1 to Day 5
Change From Baseline in RSV Nasal Swab Viral Load at Day 5		Baseline, Day 5
Time to Sustained Alleviation of Targeted RSV Symptoms by Day 28		First dose up to 28 days
Time to Resolution of Targeted RSV Symptoms by Day 28		First dose up to 28days
Assessment of Palatability and Acceptability Scores of Age-specific Formulation as Assessed by Caregiver at Days 1 and 5	Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.	Day 1 to Day 5

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Actual): April 16, 2025
• Study Completion (Actual): April 16, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Infections; Communicable Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: GS-US-685-6883; 2024-517998-24 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No