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

June 19, 2026 updated by: Gilead Sciences

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Central Alabama Research
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials
      • Guntersville, Alabama, United States, 35976
        • Lakeview Clinical Research, LLC
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Headlands Research-Scottsdale
      • Surprise, Arizona, United States, 85378
        • Epic Medical Research-Surprise
    • California
      • Canyon Country, California, United States, 91350
        • Clearview Medical Research, LLC
      • Fontana, California, United States, 92335
        • Kaiser Permanente Fontana Medica Center
      • Fresno, California, United States, 93701
        • University of California, San Francisco-Fresno
      • Los Angeles, California, United States, 90017
        • Downtown L.A. Research Center, Inc.
      • Los Angeles, California, United States, 90057
        • L.A. Universal Research Center, INC.
      • Palo Alto, California, United States, 94304
        • Stanford
      • Pomona, California, United States, 91768
        • National Institute of Clinical Research, Inc
      • Redding, California, United States, 96001
        • Paradigm Clinical Research
      • San Diego, California, United States, 92111
        • M3 Wake Research San Diego
      • Santa Maria, California, United States, 93454
        • FOMAT Medical Research - Central Coast Family Care
      • Toluca Lake, California, United States, 91602
        • Med Partners, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Allianz Research Institute- Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Paradigm Clinical Research Centers, LLC., Wheat Ridge
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Boynton Beach, Florida, United States, 33436
        • Encore Medical Research of Boynton Beach, LLC
      • Cape Coral, Florida, United States, 33990
        • C & A Clinical trials Corp
      • Coral Gables, Florida, United States, 33134
        • Prestige Clinical Research Center Inc
      • Cutler Bay, Florida, United States, 33157
        • Beautiful Minds Clinical Research Center
      • Doral, Florida, United States, 33172
        • Dolphin Medical Research
      • Doral, Florida, United States, 33126
        • UHC Research, LLC
      • Fort Lauderdale, Florida, United States, 33308
        • Proactive Clinical Research, LLC
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trials
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc.
      • Hialeah, Florida, United States, 33016
        • Doral Medical Research, LLC
      • Hialeah, Florida, United States, 33013
        • Research In Miami, Inc.
      • Hialeah, Florida, United States, 33016
        • Sync, LLC
      • Hialeah Gardens, Florida, United States, 33016
        • Evolution Clinical Trials
      • Jacksonville, Florida, United States, 32217
        • Jacksonville Center for Clinical Research
      • Jupiter, Florida, United States, 33458
        • Health Awareness, LLC
      • Lake City, Florida, United States, 32055
        • Multi-Specialty Research Associates, Inc.
      • Largo, Florida, United States, 33777
        • Accel Research Sites - St. Pete-Largo Clinical Research Unit
      • Leesburg, Florida, United States, 34748
        • Clinical Site Partners LLC dba Flourish Research
      • Miami, Florida, United States, 33126
        • LCC Medical Research Institute
      • Miami, Florida, United States, 33155
        • Miami Clinical Research
      • Miami, Florida, United States, 33155
        • Cordova Research Institute
      • Miami, Florida, United States, 33122
        • Angels Clinical Research Institute
      • Miami, Florida, United States, 33176
        • Entrust Clinical Research
      • Miami, Florida, United States, 33176
        • Reed Medical Research
      • Miami, Florida, United States, 33144
        • Nuren Medical & Research Center
      • Miami, Florida, United States, 33173
        • Research Institute of South Florida, Inc.
      • Miami, Florida, United States, 33186
        • Nuovida Research Center, Corp
      • Miami, Florida, United States, 33144
        • Clinical Trial Services, Corp
      • Miami, Florida, United States, 33175
        • Pro Live Medical Research
      • Miami, Florida, United States, 33144
        • Continental Clinical Research, LLC
      • Miami, Florida, United States, 33135
        • Retreat Medical Research
      • Miami, Florida, United States, 33155
        • Advanced Care and Clinical Trials, LLC
      • Miami, Florida, United States, 33175
        • P&S Research, LLC.
      • Miami, Florida, United States, 33176
        • Links Clinical Trials LLC
      • Miami, Florida, United States, 33144
        • Dynamic Medical Research, LLC - Miami
      • Miami, Florida, United States, 33133
        • CCM Clinical Research Group, LLC.
      • Miami Gardens, Florida, United States, 33014
        • Pro-Care Research Center
      • Miami Lakes, Florida, United States, 33014
        • Essential Clinical Research, Inc
      • Miami Lakes, Florida, United States, 33014
        • Southern Clinical Research, LLC
      • North Miami Beach, Florida, United States, 33169
        • Oceanic Research Group
      • Palm Springs, Florida, United States, 92262
        • Palm Springs Community Health Center
      • South Miami, Florida, United States, 33143
        • USPA Advance Concept Medical Research Group. LLC
      • Tampa, Florida, United States, 33615
        • Santos Research Center
      • Tampa, Florida, United States, 33614
        • Angels Clinical Research Institute
      • Tampa, Florida, United States, 33614
        • Precision Research Center Inc
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Weston, Florida, United States, 33331
        • Encore Medical Research of Weston
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • AGILE Clinical Research Trials, LLC
    • Idaho
      • Boise, Idaho, United States, 83709
        • Paradigm Clinical Research
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Metro Infectious Disease Consultants
      • Skokie, Illinois, United States, 60077
        • Endeavor Health - Clinical Trials Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
      • Webster, Iowa, United States, 77598
        • Tranquil Clinical Research
    • Kentucky
      • Versailles, Kentucky, United States, 40383
        • CCT Research- Versailles Family Medicine
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Centennial Medical Group
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Great Lakes Research Institute
    • Minnesota
      • Mankato, Minnesota, United States, 56001
        • Javara Inc.
      • Saint Paul, Minnesota, United States, 55102
        • University of Minnesota
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Hannibal Regional Healthcare System, Inc
      • Kansas City, Missouri, United States, 64151
        • Clay-Platte Family Medicine/Avacare
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Velocity Clinical Research
      • Lincoln, Nebraska, United States, 68516
        • Velocity Clinical Research
      • Lincoln, Nebraska, United States, 78681
        • Be Well Clinical Studies
      • Norfolk, Nebraska, United States, 68701
        • Velocity Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10456
        • Prime Global Research, Inc.
      • The Bronx, New York, United States, 10451
        • NYC Health and Hospitals-Lincoln
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • Raleigh, North Carolina, United States, 27612
        • Wake Research
      • Raleigh, North Carolina, United States, 27607
        • Eximia Research-NC, LLC
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lidner Research Center at The Christ Hospital
    • Oklahoma
      • Chickasha, Oklahoma, United States, 73018
        • Epic Medical Research- Oklahoma
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Velocity Clinical Research - Anderson
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Brownsville, Texas, United States, 78520
        • PanAmerican Clinical Research, LLC
      • Carrollton, Texas, United States, 75006
        • Epic Medical Research-Carrollton
      • Dallas, Texas, United States, 75224
        • WR- Global Medical Research, LLC
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77098
        • The Crofoot Research Center, INC.
      • Houston, Texas, United States, 77087
        • Santa Clara Family Clinic
      • Houston, Texas, United States, 77017
        • Vilo Research Group, Inc
      • Houston, Texas, United States, 77057
        • Diversified Medical Practices
      • Houston, Texas, United States, 77022
        • C & R Research Services USA, Inc.
      • Houston, Texas, United States, 77095
        • Next Level Urgent Care
      • Keller, Texas, United States, 76248
        • Helios Clinical Keller
      • Laredo, Texas, United States, 78041
        • Andres Garcia-Zuniga, MD, PA
      • McKinney, Texas, United States, 75069
        • Metroplex Pulmonary and Sleep Center
      • Mesquite, Texas, United States, 75149
        • SMS Clinical Research
      • Red Oak, Texas, United States, 75154
        • Epic Medical Research LLC - DeSoto
      • Sherman, Texas, United States, 75092
        • Medrasa Clinical Research
    • Utah
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research-Salt Lake City
    • Virginia
      • Portsmouth, Virginia, United States, 23703
        • Velocity Clinical Research- Suffolk
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Medical Center Everett
      • Seattle, Washington, United States, 98122
        • Swedish Organ Transplant and Liver Center
    • West Virginia
      • Kingwood, West Virginia, United States, 26537
        • Frontier Clinical Research. LLC Kingwood
      • Morgantown, West Virginia, United States, 26501
        • Frontier Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obeldesivir
Participants will receive ODV 700 mg twice on Day 1, followed by ODV 350 mg twice daily on Days 2 to 5.
Drug: Obeldesivir
Tablet administered orally
Other Names:
  • GS-5245
Experimental: Placebo
Participants will receive placebo-to-match (PTM) ODV twice daily for 5 days.
Drug: Obeldesivir Placebo
Tablet administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Through Day 15
Time Frame: Up to Day 15
RiiQ symptom scale is 13-item questionnaire (6 symptoms related to upper & lower respiratory tract & 7 systemic symptoms).Targeted RSV symptoms are 6 respiratory symptoms: nasal congestion, sore throat, cough, expectoration, shortness of breath & wheezing.Each symptom is rated on scale of None, Mild, Moderate & Severe.Alleviation of targeted RSV symptoms was defined as for 2 consecutive assessments: non-preexisting symptoms scored was None or Mild; pre-existing symptoms that were present but not worse at baseline scored same or below;& pre-existing symptoms that were worse at baseline improved at least one scale grade level. Time to alleviation of targeted RSV symptoms by Day 15 for participants with symptom alleviation was calculated as symptom alleviation date/time minus first dose date/time.For participants who completed or discontinued study by Day 15 without symptom alleviation (censored),time was calculated as last date/time on which RiiQ was assessed minus first dose date/time.
Up to Day 15
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 5 days plus 30 days
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days and that led to study drug discontinuation. Percentages are rounded off.
Up to 5 days plus 30 days
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
Time Frame: Up to 5 days plus 30 days
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point up to the date of the last dose of study drug plus 30 days. The Division of AIDS (DAIDS) Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1: mild, Grade 2: moderate, Grade 3: severe, and Grade 4: potentially life-threatening. Percentage are rounded off.
Up to 5 days plus 30 days
Percentage of Participants Who Experienced Serious Adverse Events
Time Frame: Up to 5 days plus 30 days
A serious adverse event (SAEs) is defined as an event that, at any dose, results in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. Percentage was rounded off.
Up to 5 days plus 30 days
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation
Time Frame: Up to 5 days plus 30 days
TEAEs were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days and that led to study drug discontinuation. Percentages are rounded off.
Up to 5 days plus 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Sustained Alleviation of Targeted RSV Symptoms as Measured by RiiQ Through Day 15
Time Frame: Up to Day 15
RiiQ and targeted RSV symptoms are defined in Outcome Measure #1. Each symptom is rated on scale of None, Mild, Moderate, & Severe. Sustained alleviation of targeted RSV symptoms was defined similarly to alleviation of targeted RSV symptoms but for 3 consecutive assessments. Time to sustained alleviation of targeted RSV symptoms by Day 15 for participants with sustained symptom alleviation was calculated as symptom alleviation date/time minus first dose date/time. For participants who completed or discontinued study by Day 15 without sustained symptom alleviation (censored), time was calculated as last date/time on which RiiQ was assessed minus first dose date/time.
Up to Day 15
Time to RSV-Related Lower Respiratory Tract Infection (LRTI) Through Day 29
Time Frame: Up to Day 29
RiiQ is defined in Outcome Measure #1. Lower Respiratory Tract (LRT) symptoms included cough, expectoration, shortness of breath, and wheezing. Based on RiiQ, RSV-related LRTI was defined as >=2 of the following symptoms, 1 of which must be reported as at least 'moderate' severity: new or increased cough, new or increased wheezing, new or increased shortness of breath, new or increased expectoration and participant has not met alleviation endpoints. The time to RSV-related LRTI by Day 29 for participants with RSV-related LRTI, was calculated as date/time of meeting LRTI definition minus first dose date/time. For participants who completed Day 29 of the study or discontinued from the study before Day 29 without RSV-related LRTI (censored), time was calculated as last date/time on which RiiQ was assessed minus the first dose date/time.
Up to Day 29
Time to RSV-Related Hospitalization or All-Cause Death Through Day 29
Time Frame: Up to Day 29
RSV-related hospitalization is defined as ≥ 24 hours of acute care for a reason related to RSV, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with RSV. RSV relatedness was determined by investigator. KM estimates were used in analysis.
Up to Day 29
Time to RSV-Related Medically Attended Visit or All-Cause Death Through Day 29
Time Frame: Up to Day 29
Medically attended visits (MAV) are defined as any interactions with health care professionals other than study staff or designees, including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. RSV relatedness was determined by the investigator. KM estimates were used in analysis.
Up to Day 29
RSV Viral Load At Baseline
Time Frame: Baseline
The RSV viral load results were obtained from UTM (universal transport medium) nasal swab samples collected at Baseline.
Baseline
Change From Baseline in RSV Viral Load Through Day 3
Time Frame: Baseline, Day 3
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 3.
Baseline, Day 3
Change From Baseline in RSV Viral Load Through Day 5
Time Frame: Baseline, Day 5
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 5.
Baseline, Day 5
Change From Baseline in RSV Viral Load Through Day 7
Time Frame: Baseline, Day 7
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 7.
Baseline, Day 7
Change From Baseline in RSV Viral Load Through Day 10
Time Frame: Baseline, Day 10
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 10.
Baseline, Day 10
Change From Baseline in RSV Viral Load Through Day 15
Time Frame: Baseline, Day 15
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 15.
Baseline, Day 15
Pharmacokinetic (PK) Parameter: AUCtau of GS-441524, Metabolite of Obeldesivir
Time Frame: Day 5: Pre-dose and at multiple timepoints (up to 12 hours) post-dose
AUCtau is defined as area under the plasma concentration-time curve during a dosing interval.
Day 5: Pre-dose and at multiple timepoints (up to 12 hours) post-dose
PK Parameter: Ctrough of GS-441524, Metabolite of Obeldesivir
Time Frame: Day 5 (predose)
Ctrough is defined as the concentration at the end of the dosing interval.
Day 5 (predose)
PK Parameter: Cmax of GS-441524, Metabolite of Obeldesivir
Time Frame: Day 1 (At multiple timepoints [up to 4 hours] post-dose); Day 5 (Pre-dose and at multiple timepoints [up to 4 hours] post-dose)
Cmax is defined as the maximum observed concentration of drug in plasma.
Day 1 (At multiple timepoints [up to 4 hours] post-dose); Day 5 (Pre-dose and at multiple timepoints [up to 4 hours] post-dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Actual)

May 8, 2025

Study Completion (Actual)

June 9, 2025

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Actual)

September 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-685-6819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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