drugset / Trial / NCT06585150

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

NCT06585150 ↗

Phase 2 Terminated 150 enrolled Gilead Sciences
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this clinical study was to learn more about the study drug, obeldesivir (ODV; GS-5245), and how safe and effective it was in treating nonhospitalized adults with acute respiratory syncytial virus (RSV) infection. The researchers wanted to see if obeldesivir can help participants' symptoms get better faster. The primary objectives of this study were to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV in nonhospitalized adult participants with acute RSV infection.

Timeline

Start
2024-10-14
Primary completion
2025-05-08
Completion
2025-06-09

Outcome

Missed primary endpoint

Stopped: “Study was terminated by Sponsor; the decision was not due to any safety findings.”

registry analysis (superiority test); Obeldesivir vs Placebo; p = 0.2005; Difference in median time -0.7; Stratified Log-Rank Test NCT06585150 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Obeldesivir Small molecule 350 mg Oral