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Treatment of RSV infection in children using obeldesivir

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

PHASE2 · Gilead Sciences · NCT06784973

This study is testing if a new medicine called obeldesivir can help young children with RSV infection feel better faster and if it's safe for them to use.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment130 (estimated)
AgesN/A to 5 Years
SexAll
SponsorGilead Sciences (industry)
Drugs / interventionspalivizumab, nirsevimab
Locations57 sites (Birmingham, Alabama and 56 other locations)
Trial IDNCT06784973 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and tolerability of obeldesivir (ODV) in children diagnosed with respiratory syncytial virus (RSV) infection. It will also assess how effectively ODV reduces the duration of RSV symptoms in pediatric patients. Participants will be divided into two cohorts based on age and weight, with infants and children from 4 weeks to under 5 years eligible for inclusion. The study will involve administering either ODV or a placebo to determine the treatment's efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are infants and children aged from 4 weeks to under 5 years who have been diagnosed with RSV infection.

Not a fit: Patients requiring hospitalization for RSV infection within 48 hours of randomization will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery times for children suffering from RSV infection.

How similar studies have performed: Other studies have explored antiviral treatments for RSV, but the specific use of obeldesivir in this pediatric population is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: RSV Infection

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.