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NCT06585150

PHASE2

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-10-14

Completion Date

2025-06-09

Last Updated

2026-06-30

Healthy Volunteers

Conditions

RSV Infection

Interventions

DRUG

Obeldesivir

Tablet administered orally

DRUG

Obeldesivir Placebo

Tablet administered orally

Key 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 * New onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity at screening, and onset ≤ 3 days before randomization. * a) Nasal congestion. * b) Sore throat. * c) Cough. * d) Wheezing. * e) Shortness of breath (ie, dyspnea). * f) Expectoration (ie, sputum production). * RSV vaccine status: * Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV. Key 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 systemic 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. * Alanine aminotransferase ≥ 5 x upper limit of normal within 6 months prior to randomization, unless confirmed as resolved at screening. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Stanford

Palo Alto, California, United States

National Institute of Clinical Research, Inc

Pomona, California, United States

Paradigm Clinical Research

Redding, California, United States

M3 Wake Research San Diego

San Diego, California, United States

FOMAT Medical Research - Central Coast Family Care

Santa Maria, California, United States

Med Partners, Inc.

Toluca Lake, California, United States

Allianz Research Institute- Colorado

Aurora, Colorado, United States

Paradigm Clinical Research Centers, LLC., Wheat Ridge

Wheat Ridge, Colorado, United States

Yale University

New Haven, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Encore Medical Research of Boynton Beach, LLC

Boynton Beach, Florida, United States

C & A Clinical trials Corp

Cape Coral, Florida, United States

Prestige Clinical Research Center Inc

Coral Gables, Florida, United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

UHC Research, LLC

Doral, Florida, United States

Dolphin Medical Research

Doral, Florida, United States

Proactive Clinical Research, LLC

Fort Lauderdale, Florida, United States

Aga Clinical Trials