NCT06784973

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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

Conditions

• RSV Infection

Interventions

Type	Name	Description
DRUG	Obeldesivir	Administered orally
DRUG	Obeldesivir Placebo	Administered orally

Timeline

• Start date: 2025-03-05
• Primary completion: 2025-04-16
• Completion: 2025-04-16
• First posted: 2025-01-20
• Last updated: 2025-06-25

Locations

56 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study