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

NCT06784973 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-685-6883jRCT2031240735
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 56

Brief 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.

Conditions

RSV Infection

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) by Day 28

  TEAEs were defined as any adverse events that began on or after the date of first dose of study drug up to the date of last dose of study drug up to Day 28. The percentage of participants who experienced at least one TEAE was assessed from Day 1 through Day 28.

  Up to Day 28

• Percentage of Participants Who Experienced Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities by Day 28

  A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose up to Day 28. A treatment-emergent laboratory abnormality severity was graded according to the Division of AIDS (DAIDS) Version 2.1. Grade 0: Values that do not meet the criteria for an abnormality of at least Grade 1;Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially life-threatening. The percentage of participants who experienced Grade 3 or 4 laboratory abnormalities was assessed from Day 1 through Day 28.

  Up to Day 28

• Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms by Day 28

  Alleviation of targeted RSV symptoms was defined as achievement of 2 consecutive daily assessments with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is \> 1, or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact).

  Up to Day 28

Secondary Outcomes (8)

• PK Parameter: AUCtau of GS-441524, Metabolite of Obeldesivir

  Day 5 (predose, 2.5, and 3.5 hours post-dose)

• PK Parameter: Cmax of GS-441524, Metabolite of Obeldesivir

  Day 1 (0.25, 0.75, and 2 hours post-dose); Day 5 (predose, 2.5, and 3.5 hours post-dose)

• PK Parameter: Ctrough of GS-441524, Metabolite of Obeldesivir

  Day 5: Predose

• 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

  Up to Day 28

Study Arms (3)

Cohort 1: Part A (Group 2) - Obeldesivir (ODV)

EXPERIMENTAL

Participants weighing ≥ 12 kg to \< 20 kg, will receive ODV 175 mg, orally, twice on Day 1, followed by ODV 116.6 mg, orally, twice daily on Days 2 to 5.

Drug: Obeldesivir

Cohort 1: Part A (Group 3) - ODV

EXPERIMENTAL

Participants weighing ≥ 6 kg to \< 12 kg, will receive ODV 116.6 mg, orally, twice on Day 1, followed by ODV 58.3 mg, orally, twice daily on Days 2 to 5.

Drug: Obeldesivir

Cohort 1: Part A (Group 3) - Placebo

PLACEBO COMPARATOR

Participants weighing ≥ 6 kg to \< 12 kg, will receive placebo-to-match ODV, orally, twice daily on Days 1 to 5.

Drug: Obeldesivir Placebo

Interventions

Obeldesivir DRUG

Administered orally

Also known as: ODV, GS-5245

Cohort 1: Part A (Group 2) - Obeldesivir (ODV); Cohort 1: Part A (Group 3) - ODV

Obeldesivir Placebo DRUG

Administered orally

Cohort 1: Part A (Group 3) - Placebo

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (56)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Midway Medical Clinic

Oneonta, Alabama, 35121, United States

Location

Cohen Children's Medical Center Pharmacy New Pavillion

Phoenix, Arizona, 11040, United States

Location

Velocity Clinical Research, Phoenix

Phoenix, Arizona, 85015, United States

Location

UCLA (Outpatient Clinic)

Los Angeles, California, 90095, United States

Location

Alliance Research Institute

Lynwood, California, 90262, United States

Location

Paradigm Clinical Research

Modesto, California, 95355, United States

Location

Paradigm Clinical Research Centers, LLC

San Diego, California, 92108, United States

Location

FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine

Santa Maria, California, 93454, United States

Location

Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia, 20016, United States

Location

Dolphin Medical Research

Doral, Florida, 33172, United States

Location

Nona Pediatric Center

Orlando, Florida, 32829, United States

Location

PAS Research

Tampa, Florida, 33613, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Velocity Clinical Research, Sioux City

Sioux City, Iowa, 51106, United States

Location

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, 70508, United States

Location

Boeson Research

Great Falls, Montana, 59405, United States

Location

Boeson Research

Kalispell, Montana, 59901, United States

Location

Boeson Research

Missoula, Montana, 59804, United States

Location

Velocity Clinical Research - Norfolk

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

Child Health Care Associates

Syracuse, New York, 13210, United States

Location

Epic Medical Research -Oklahoma

Chickasha, Oklahoma, 73018, United States

Location

Tekton Research, LLC

Yukon, Oklahoma, 73099, United States

Location

PAS Research

Pittsburgh, Pennsylvania, 15227, United States

Location

Helios Clinical Research

Burleson, Texas, 76028, United States

Location

Epic Medical Research - DeSoto

DeSoto, Texas, 75115, United States

Location

PAS Research

Edinburg, Texas, 78539, United States

Location

Helios Clinical Research

Houston, Texas, 77008, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Sunrise Pediatrics

Houston, Texas, 77077, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

Pioneer Research Solutions Inc.

Houston, Texas, 77099, United States

Location

Radiance Clinical Research

Lampasas, Texas, 76550, United States

Location

Pediatric Center

Richmond, Texas, 77469, United States

Location

Central Texas Medical Research, LLC

San Antonio, Texas, 78232, United States

Location

North Houston Internal Medicine and Pediatric Clinic

Tomball, Texas, 77375, United States

Location

Tanner Clinic

Kaysville, Utah, 84037, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Boeson Research PVU

Provo, Utah, 84604, United States

Location

Yoshimura Child Clinic

Akashi, 674-0068, Japan

Location

Japan Community Healthcare Organization Kyushu Hospital

Fkitakyushu, 806-0034, Japan

Location

Uchida child clinic

Fukuoka, 814-0104, Japan

Location

Shindo Children's Clinic

Fukuoka, 814-0121, Japan

Location

SEKI Children's CLINIC

Fukuoka, 814-0123, Japan

Location

Ryuseidai Children's Clinic

Ibaraki, 305-0008, Japan

Location

Isesaki Municipal Hospital

Isesaki, 372-0817, Japan

Location

Abe Child Clinic

Kanagawa, 223-0051, Japan

Location

Okada Kodomonomori Clinic

Kasukabe, 344-0011, Japan

Location

Yutaka Children Clinic

Kobe, 651-2273, Japan

Location

Kochi Health Sciences Center

Kochi, 781-8555, Japan

Location

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, Japan

Location

Shimamura Memorial Hospital

Nerima-ku, 177-0051, Japan

Location

Shizuoka Welfare Hospital

Shizuoka, 420-0005, Japan

Location

Shizuoka City Shimizu Hospital

Shizuoka, 424-8636, Japan

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: March 5, 2025
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: June 8, 2026
• Results First Posted: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (41); JP (15)