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

NCT06585150 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: GS-US-685-6819
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 121

Brief 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.

Conditions

RSV Infection

Outcome Measures

Primary Outcomes (5)

• Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Through 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)

  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

  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

  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

  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 Outcomes (13)

• Time to Sustained Alleviation of Targeted RSV Symptoms as Measured by RiiQ Through Day 15

  Up to Day 15

• Time to RSV-Related Lower Respiratory Tract Infection (LRTI) Through Day 29

  Up to Day 29

• Time to RSV-Related Hospitalization or All-Cause Death Through Day 29

  Up to Day 29

• Time to RSV-Related Medically Attended Visit or All-Cause Death Through Day 29

  Up to Day 29

• RSV Viral Load At Baseline

  Baseline

Study Arms (2)

Obeldesivir

EXPERIMENTAL

Participants will receive ODV 700 mg twice on Day 1, followed by ODV 350 mg twice daily on Days 2 to 5.

Drug: Obeldesivir

Placebo

EXPERIMENTAL

Participants will receive placebo-to-match (PTM) ODV twice daily for 5 days.

Drug: Obeldesivir Placebo

Interventions

Obeldesivir DRUG

Tablet administered orally

Also known as: GS-5245

Obeldesivir

Obeldesivir Placebo DRUG

Tablet administered orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exhibits at least 1 of the following risk factors for severe RSV disease:
• Age ≥ 60 years
• Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.
• Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
• One or more of the following chronic lung diseases:
• i) Bronchiectasis
• ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)
• iii) Pulmonary hypertension
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (121)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Lakeview Clinical Research, LLC

Guntersville, Alabama, 35976, United States

Location

Headlands Research-Scottsdale

Scottsdale, Arizona, 85260, United States

Location

Epic Medical Research-Surprise

Surprise, Arizona, 85378, United States

Location

Clearview Medical Research, LLC

Canyon Country, California, 91350, United States

Location

Kaiser Permanente Fontana Medica Center

Fontana, California, 92335, United States

Location

University of California, San Francisco-Fresno

Fresno, California, 93701, United States

Location

Downtown L.A. Research Center, Inc.

Los Angeles, California, 90017, United States

Location

L.A. Universal Research Center, INC.

Los Angeles, California, 90057, United States

Location

Stanford

Palo Alto, California, 94304, United States

Location

National Institute of Clinical Research, Inc

Pomona, California, 91768, United States

Location

Paradigm Clinical Research

Redding, California, 96001, United States

Location

M3 Wake Research San Diego

San Diego, California, 92111, United States

Location

FOMAT Medical Research - Central Coast Family Care

Santa Maria, California, 93454, United States

Location

Med Partners, Inc.

Toluca Lake, California, 91602, United States

Location

Allianz Research Institute- Colorado

Aurora, Colorado, 80014, United States

Location

Paradigm Clinical Research Centers, LLC., Wheat Ridge

Wheat Ridge, Colorado, 80033, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Encore Medical Research of Boynton Beach, LLC

Boynton Beach, Florida, 33436, United States

Location

C & A Clinical trials Corp

Cape Coral, Florida, 33990, United States

Location

Prestige Clinical Research Center Inc

Coral Gables, Florida, 33134, United States

Location

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, 33157, United States

Location

UHC Research, LLC

Doral, Florida, 33126, United States

Location

Dolphin Medical Research

Doral, Florida, 33172, United States

Location

Proactive Clinical Research, LLC

Fort Lauderdale, Florida, 33308, United States

Location

Aga Clinical Trials

Hialeah, Florida, 33012, United States

Location

Indago Research & Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Research In Miami, Inc.

Hialeah, Florida, 33013, United States

Location

Doral Medical Research, LLC

Hialeah, Florida, 33016, United States

Location

Sync, LLC

Hialeah, Florida, 33016, United States

Location

Evolution Clinical Trials

Hialeah Gardens, Florida, 33016, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32217, United States

Location

Health Awareness, LLC

Jupiter, Florida, 33458, United States

Location

Multi-Specialty Research Associates, Inc.

Lake City, Florida, 32055, United States

Location

Accel Research Sites - St. Pete-Largo Clinical Research Unit

Largo, Florida, 33777, United States

Location

Clinical Site Partners LLC dba Flourish Research

Leesburg, Florida, 34748, United States

Location

Angels Clinical Research Institute

Miami, Florida, 33122, United States

Location

LCC Medical Research Institute

Miami, Florida, 33126, United States

Location

CCM Clinical Research Group, LLC.

Miami, Florida, 33133, United States

Location

Retreat Medical Research

Miami, Florida, 33135, United States

Location

Clinical Trial Services, Corp

Miami, Florida, 33144, United States

Location

Continental Clinical Research, LLC

Miami, Florida, 33144, United States

Location

Dynamic Medical Research, LLC - Miami

Miami, Florida, 33144, United States

Location

Nuren Medical & Research Center

Miami, Florida, 33144, United States

Location

Advanced Care and Clinical Trials, LLC

Miami, Florida, 33155, United States

Location

Cordova Research Institute

Miami, Florida, 33155, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Research Institute of South Florida, Inc.

Miami, Florida, 33173, United States

Location

P&S Research, LLC.

Miami, Florida, 33175, United States

Location

Pro Live Medical Research

Miami, Florida, 33175, United States

Location

Entrust Clinical Research

Miami, Florida, 33176, United States

Location

Links Clinical Trials LLC

Miami, Florida, 33176, United States

Location

Reed Medical Research

Miami, Florida, 33176, United States

Location

Nuovida Research Center, Corp

Miami, Florida, 33186, United States

Location

Pro-Care Research Center

Miami Gardens, Florida, 33014, United States

Location

Essential Clinical Research, Inc

Miami Lakes, Florida, 33014, United States

Location

Southern Clinical Research, LLC

Miami Lakes, Florida, 33014, United States

Location

Oceanic Research Group

North Miami Beach, Florida, 33169, United States

Location

Palm Springs Community Health Center

Palm Springs, Florida, 92262, United States

Location

USPA Advance Concept Medical Research Group. LLC

South Miami, Florida, 33143, United States

Location

Angels Clinical Research Institute

Tampa, Florida, 33614, United States

Location

Precision Research Center Inc

Tampa, Florida, 33614, United States

Location

Santos Research Center

Tampa, Florida, 33615, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Encore Medical Research of Weston

Weston, Florida, 33331, United States

Location

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

Location

Paradigm Clinical Research

Boise, Idaho, 83709, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Metro Infectious Disease Consultants

Burr Ridge, Illinois, 60527, United States

Location

Endeavor Health - Clinical Trials Center

Skokie, Illinois, 60077, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Tranquil Clinical Research

Webster, Iowa, 77598, United States

Location

CCT Research- Versailles Family Medicine

Versailles, Kentucky, 40383, United States

Location

Centennial Medical Group

Columbia, Maryland, 21045, United States

Location

Great Lakes Research Institute

Southfield, Michigan, 48075, United States

Location

Javara Inc.

Mankato, Minnesota, 56001, United States

Location

University of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

Hannibal Regional Healthcare System, Inc

Hannibal, Missouri, 63401, United States

Location

Clay-Platte Family Medicine/Avacare

Kansas City, Missouri, 64151, United States

Location

Velocity Clinical Research

Lincoln, Nebraska, 68510, United States

Location

Velocity Clinical Research

Lincoln, Nebraska, 68516, United States

Location

Be Well Clinical Studies

Lincoln, Nebraska, 78681, United States

Location

Velocity Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Clinical Research of South Nevada

Las Vegas, Nevada, 89121, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Prime Global Research, Inc.

New York, New York, 10456, United States

Location

NYC Health and Hospitals-Lincoln

The Bronx, New York, 10451, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Eximia Research-NC, LLC

Raleigh, North Carolina, 27607, United States

Location

Wake Research

Raleigh, North Carolina, 27612, United States

Location

Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States

Location

The Lidner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Epic Medical Research- Oklahoma

Chickasha, Oklahoma, 73018, United States

Location

Velocity Clinical Research - Anderson

Anderson, South Carolina, 29621, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Inquest Clinical Research

Baytown, Texas, 77521, United States

Location

PanAmerican Clinical Research, LLC

Brownsville, Texas, 78520, United States

Location

Epic Medical Research-Carrollton

Carrollton, Texas, 75006, United States

Location

WR- Global Medical Research, LLC

Dallas, Texas, 75224, United States

Location

Vilo Research Group, Inc

Houston, Texas, 77017, United States

Location

C & R Research Services USA, Inc.

Houston, Texas, 77022, United States

Location

Diversified Medical Practices

Houston, Texas, 77057, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Santa Clara Family Clinic

Houston, Texas, 77087, United States

Location

Next Level Urgent Care

Houston, Texas, 77095, United States

Location

The Crofoot Research Center, INC.

Houston, Texas, 77098, United States

Location

Helios Clinical Keller

Keller, Texas, 76248, United States

Location

Andres Garcia-Zuniga, MD, PA

Laredo, Texas, 78041, United States

Location

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Epic Medical Research LLC - DeSoto

Red Oak, Texas, 75154, United States

Location

Medrasa Clinical Research

Sherman, Texas, 75092, United States

Location

Velocity Clinical Research-Salt Lake City

West Jordan, Utah, 84088, United States

Location

Velocity Clinical Research- Suffolk

Portsmouth, Virginia, 23703, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

Swedish Organ transplant and Liver Center

Seattle, Washington, 98122, United States

Location

Frontier Clinical Research. LLC Kingwood

Kingwood, West Virginia, 26537, United States

Location

Frontier Clinical Research, LLC

Morgantown, West Virginia, 26501, United States

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: October 14, 2024
• Primary Completion: May 8, 2025
• Study Completion: June 9, 2025
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (121)