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Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Phase 2 Randomized, Placebo-controlled Study of the Safety and Efficacy of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

NCT06585150•Gilead Sciences

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV; GS-5245), and how safe and effective it is in treating nonhospitalized adults with acute respiratory syncytial virus (RSV) infection. The researchers want to see if obeldesivir can help participants' symptoms get better faster. The primary objectives of this study are 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Exhibits at least 1 of the following risk factors for severe RSV disease:
•1. Age ≥ 60 years
•2. Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.
•3. Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
•4. One or more of the following chronic lung diseases:
•* i) Bronchiectasis
•* ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)
•* iii) Pulmonary hypertension
•5. Chronic cardiovascular disease exclusive of hypertension
•RSV infection confirmed ≤ 3 days before randomization
+3 more criteria

Exclusion Criteria

•Currently requiring or expected to require hospitalization within 48 hours after randomization.
•Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
•Documented to be positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 7 days prior to randomization.
•Concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization.
•Individuals with a history of cystic fibrosis.
•Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization.
•Pregnant at screening.
•Received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against RSV \< 28 days or \< 5 half-lives, whichever is longer, before randomization.
•Received an investigational product \< 28 days or \< 5 half-lives, whichever is longer, before randomization.

Locations (121)

Central Alabama Research

Birmingham, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

Lakeview Clinical Research, LLC

Guntersville, Alabama, United States

Headlands Research-Scottsdale

Scottsdale, Arizona, United States

Epic Medical Research-Surprise

Surprise, Arizona, United States

Clearview Medical Research, LLC

Canyon Country, California, United States

Kaiser Permanente Fontana Medica Center

Fontana, California, United States

University of California, San Francisco-Fresno

Fresno, California, United States

Downtown L.A. Research Center, Inc.

Los Angeles, California, United States

L.A. Universal Research Center, INC.

Los Angeles, California, United States

Key Dates

Start Date

October 14, 2024

Primary Completion Date

May 8, 2025

Completion Date

June 9, 2025

Last Updated

July 28, 2025

Enrollment

150

ACTUAL participants

Conditions

RSV Infection

Interventions

Obeldesivir

DRUG

Obeldesivir Placebo

DRUG

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

NCT03596801

RSV Infection

View study

COMPLETEDPHASE1

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

NCT06583031

RSV InfectionhMPV

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit