Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
NCT ID: NCT06784973
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2025-03-05
2025-04-16
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Obeldesivir
Participants will receive an age and weight appropriate ODV dose based on their cohort/group assignment.
Obeldesivir
Administered orally
Obeldesivir Placebo
Participants will receive an age and weight appropriate ODV placebo dose based on their cohort/group assignment.
Obeldesivir Placebo
Administered orally
Interventions
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Obeldesivir
Administered orally
Obeldesivir Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
5 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2024-517998-24
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-685-6883
Identifier Type: -
Identifier Source: org_study_id
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