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Study of Obeldesivir to Treat...

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

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2025-06-09

Brief Summary

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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.

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Detailed Description

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Conditions

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RSV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Obeldesivir (ODV)

Participants will receive obeldesivir for 5 days

Group Type EXPERIMENTAL

Obeldesivir

Intervention Type DRUG

Tablet administered orally

Placebo comparator: Obeldesivir Placebo

Participants will receive obeldesivir placebo for 5 days

Group Type EXPERIMENTAL

Obeldesivir Placebo

Intervention Type DRUG

Tablet administered orally

Interventions

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Obeldesivir

Tablet administered orally

Intervention Type DRUG

Obeldesivir Placebo

Tablet administered orally

Intervention Type DRUG

Other Intervention Names

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GS-5245

Eligibility Criteria

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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 a screening, and onset ≤ 3 days before randomization.
* RSV vaccine status:

* Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Central Alabama Research

Birmingham, Alabama, United States

Site Status

Cullman Clinical Trials

Cullman, Alabama, United States

Site Status

Lakeview Clinical Research, LLC

Guntersville, Alabama, United States

Site Status

Headlands Research-Scottsdale

Scottsdale, Arizona, United States

Site Status

Epic Medical Research-Surprise

Surprise, Arizona, United States

Site Status

Clearview Medical Research, LLC

Canyon Country, California, United States

Site Status

Kaiser Permanente Fontana Medica Center

Fontana, California, United States

Site Status

University of California, San Francisco-Fresno

Fresno, California, United States

Site Status

Downtown L.A. Research Center, Inc.

Los Angeles, California, United States

Site Status

L.A. Universal Research Center, INC.

Los Angeles, California, United States

Site Status

Stanford

Palo Alto, California, United States

Site Status

National Institute of Clinical Research, Inc

Pomona, California, United States

Site Status

Paradigm Clinical Research

Redding, California, United States

Site Status

M3 Wake Research San Diego

San Diego, California, United States

Site Status

FOMAT Medical Research - Central Coast Family Care

Santa Maria, California, United States

Site Status

Med Partners, Inc.

Toluca Lake, California, United States

Site Status

Allianz Research Institute- Colorado

Aurora, Colorado, United States

Site Status

Paradigm Clinical Research Centers, LLC., Wheat Ridge

Wheat Ridge, Colorado, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Georgetown University Medical Center

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

Site Status

Encore Medical Research of Boynton Beach, LLC

Boynton Beach, Florida, United States

Site Status

C & A Clinical trials Corp

Cape Coral, Florida, United States

Site Status

Prestige Clinical Research Center Inc

Coral Gables, Florida, United States

Site Status

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

Site Status

UHC Research, LLC

Doral, Florida, United States

Site Status

Dolphin Medical Research

Doral, Florida, United States

Site Status