Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
- Registration Number
- NCT06784973
- Lead Sponsor
- Gilead Sciences
- 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.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
-
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.
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Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
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Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.
Key
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obeldesivir Placebo Obeldesivir Placebo Participants will receive an age and weight appropriate ODV placebo dose based on their cohort/group assignment. Obeldesivir Obeldesivir Participants will receive an age and weight appropriate ODV dose based on their cohort/group assignment.
- Primary Outcome Measures
Name Time Method Time to Alleviation of Targeted RSV Symptoms by Day 28 First dose up to 28 days 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
- Secondary Outcome Measures
Name Time Method Pharmacokinetic (PK) parameter AUCtau of ODV metabolite, GS-441524 Day 1 to Day 5 AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
PK parameter Cmax of ODV metabolite, GS-441524 Day 1 to Day 5 Cmax is defined as the concentration at the end of the dosing interval.
PK parameter Ctrough of ODV metabolite, GS-441524 Day 1 to Day 5 Ctrough is defined as the concentration at the endo of the dosing interval.
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 Day 1 to Day 5 Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.
Related Research Topics
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Trial Locations
- Locations (49)
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, District of Columbia, United States
Scroll for more (39 remaining)Children's of Alabama🇺🇸Birmingham, Alabama, United States