Study Details

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

RSV Infection

Gender

N/A

Date

October 2024 - September 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Obeldesivir, Obeldesivir Placebo

Eligibility Information

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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (121)

Central Alabama Research

Birmingham, Alabama, United States, 35209

Cullman Clinical Trials

Cullman, Alabama, United States, 35055

Lakeview Clinical Research, LLC

Guntersville, Alabama, United States, 35976

Headlands Research-Scottsdale

Scottsdale, Arizona, United States, 85260

Epic Medical Research-Surprise

Surprise, Arizona, United States, 85378

Clearview Medical Research, LLC

Canyon Country, California, United States, 91350

Kaiser Permanente Fontana Medica Center

Fontana, California, United States, 92335

University of California, San Francisco-Fresno

Fresno, California, United States, 93701

Downtown L.A. Research Center, Inc.

Los Angeles, California, United States, 90017

L.A. Universal Research Center, INC.

Los Angeles, California, United States, 90057

Stanford

Palo Alto, California, United States, 94304

National Institute of Clinical Research, Inc

Pomona, California, United States, 91768

Paradigm Clinical Research

Redding, California, United States, 96001

M3 Wake Research San Diego

San Diego, California, United States, 92111

FOMAT Medical Research - Central Coast Family Care

Santa Maria, California, United States, 93454

Med Partners, Inc.

Toluca Lake, California, United States, 91602

Allianz Research Institute- Colorado

Aurora, Colorado, United States, 80014

Paradigm Clinical Research Centers, LLC., Wheat Ridge

Wheat Ridge, Colorado, United States, 80033

Yale University

New Haven, Connecticut, United States, 06510

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

Encore Medical Research of Boynton Beach, LLC

Boynton Beach, Florida, United States, 33436

C & A Clinical trials Corp

Cape Coral, Florida, United States, 33990

Prestige Clinical Research Center Inc

Coral Gables, Florida, United States, 33134

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States, 33157

UHC Research, LLC

Doral, Florida, United States, 33126

Dolphin Medical Research

Doral, Florida, United States, 33172

Proactive Clinical Research, LLC

Fort Lauderdale, Florida, United States, 33308

Evolution Clinical Trials

Hialeah Gardens, Florida, United States, 33016

Aga Clinical Trials

Hialeah, Florida, United States, 33012

Indago Research & Health Center, Inc.

Hialeah, Florida, United States, 33012

Research In Miami, Inc.

Hialeah, Florida, United States, 33013

Doral Medical Research, LLC

Hialeah, Florida, United States, 33016

Sync, LLC

Hialeah, Florida, United States, 33016

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States, 32217

Health Awareness, LLC

Jupiter, Florida, United States, 33458

Multi-Specialty Research Associates, Inc.

Lake City, Florida, United States, 32055

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

Largo, Florida, United States, 33777

Clinical Site Partners LLC dba Flourish Research

Leesburg, Florida, United States, 34748

Pro-Care Research Center

Miami Gardens, Florida, United States, 33014

Essential Clinical Research, Inc

Miami Lakes, Florida, United States, 33014

Southern Clinical Research, LLC

Miami Lakes, Florida, United States, 33014

Angels Clinical Research Institute

Miami, Florida, United States, 33122

LCC Medical Research Institute

Miami, Florida, United States, 33126

CCM Clinical Research Group, LLC.

Miami, Florida, United States, 33133

Retreat Medical Research

Miami, Florida, United States, 33135

Clinical Trial Services, Corp

Miami, Florida, United States, 33144

Continental Clinical Research, LLC

Miami, Florida, United States, 33144

Dynamic Medical Research, LLC - Miami

Miami, Florida, United States, 33144

Nuren Medical & Research Center

Miami, Florida, United States, 33144

Advanced Care and Clinical Trials, LLC

Miami, Florida, United States, 33155

Cordova Research Institute

Miami, Florida, United States, 33155

Miami Clinical Research

Miami, Florida, United States, 33155

Research Institute of South Florida, Inc.

Miami, Florida, United States, 33173

P&S Research, LLC.

Miami, Florida, United States, 33175

Pro Live Medical Research

Miami, Florida, United States, 33175

Entrust Clinical Research

Miami, Florida, United States, 33176

Links Clinical Trials LLC

Miami, Florida, United States, 33176

Reed Medical Research

Miami, Florida, United States, 33176

Nuovida Research Center, Corp

Miami, Florida, United States, 33186

Oceanic Research Group

North Miami Beach, Florida, United States, 33169

Palm Springs Community Health Center

Palm Springs, Florida, United States, 92262

USPA Advance Concept Medical Research Group. LLC

South Miami, Florida, United States, 33143

Angels Clinical Research Institute

Tampa, Florida, United States, 33614

Precision Research Center Inc

Tampa, Florida, United States, 33614

Santos Research Center

Tampa, Florida, United States, 33615

Palm Beach Research Center

West Palm Beach, Florida, United States, 33409

Encore Medical Research of Weston

Weston, Florida, United States, 33331

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States, 30328

Paradigm Clinical Research

Boise, Idaho, United States, 83709

Clinical Research Prime

Idaho Falls, Idaho, United States, 83404

Metro Infectious Disease Consultants

Burr Ridge, Illinois, United States, 60527

Endeavor Health - Clinical Trials Center

Skokie, Illinois, United States, 60077

University of Iowa

Iowa City, Iowa, United States, 52242

Tranquil Clinical Research

Webster, Iowa, United States, 77598

CCT Research- Versailles Family Medicine

Versailles, Kentucky, United States, 40383

Centennial Medical Group

Columbia, Maryland, United States, 21045

Great Lakes Research Institute

Southfield, Michigan, United States, 48075

Javara Inc.

Mankato, Minnesota, United States, 56001

University of Minnesota

Saint Paul, Minnesota, United States, 55102

Hannibal Regional Healthcare System, Inc

Hannibal, Missouri, United States, 63401

Clay-Platte Family Medicine/Avacare

Kansas City, Missouri, United States, 64151

Velocity Clinical Research

Lincoln, Nebraska, United States, 68510

Velocity Clinical Research

Lincoln, Nebraska, United States, 68516

Be Well Clinical Studies

Lincoln, Nebraska, United States, 78681

Velocity Clinical Research

Norfolk, Nebraska, United States, 68701

Clinical Research of South Nevada

Las Vegas, Nevada, United States, 89121

NYC Health and Hospitals-Lincoln

Bronx, New York, United States, 10451

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Weill Cornell Medicine

New York, New York, United States, 10065

Prime Global Research, Inc.

New York, New York, United States, 10456

Monroe Biomedical Research

Monroe, North Carolina, United States, 28112

Eximia Research-NC, LLC

Raleigh, North Carolina, United States, 27607

Wake Research

Raleigh, North Carolina, United States, 27612

Trial Management Associates, LLC

Wilmington, North Carolina, United States, 28403

The Lidner Research Center at The Christ Hospital

Cincinnati, Ohio, United States, 45219

Epic Medical Research- Oklahoma

Chickasha, Oklahoma, United States, 73018

Velocity Clinical Research - Anderson

Anderson, South Carolina, United States, 29621

Central Texas Clinical Research

Austin, Texas, United States, 78705

Inquest Clinical Research

Baytown, Texas, United States, 77521

PanAmerican Clinical Research, LLC

Brownsville, Texas, United States, 78520

Epic Medical Research-Carrollton

Carrollton, Texas, United States, 75006

WR- Global Medical Research, LLC

Dallas, Texas, United States, 75224

Vilo Research Group, Inc

Houston, Texas, United States, 77017

C & R Research Services USA, Inc.

Houston, Texas, United States, 77022

Diversified Medical Practices

Houston, Texas, United States, 77057

Clinical Trial Network

Houston, Texas, United States, 77074

Santa Clara Family Clinic

Houston, Texas, United States, 77087

Next Level Urgent Care

Houston, Texas, United States, 77095

The Crofoot Research Center, INC.

Houston, Texas, United States, 77098

Helios Clinical Keller

Keller, Texas, United States, 76248

Andres Garcia-Zuniga, MD, PA

Laredo, Texas, United States, 78041

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States, 75069

SMS Clinical Research

Mesquite, Texas, United States, 75149

Epic Medical Research LLC - DeSoto

Red Oak, Texas, United States, 75154

Medrasa Clinical Research

Sherman, Texas, United States, 75092

Velocity Clinical Research-Salt Lake City

West Jordan, Utah, United States, 84088

Velocity Clinical Research- Suffolk

Portsmouth, Virginia, United States, 23703

Providence Regional Medical Center Everett

Everett, Washington, United States, 98201

Swedish Organ transplant and Liver Center

Seattle, Washington, United States, 98122

Frontier Clinical Research. LLC Kingwood

Kingwood, West Virginia, United States, 26537

Frontier Clinical Research, LLC

Morgantown, West Virginia, United States, 26501

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (121)

Central Alabama Research

Cullman Clinical Trials

Lakeview Clinical Research, LLC

Headlands Research-Scottsdale

Epic Medical Research-Surprise

Clearview Medical Research, LLC

Kaiser Permanente Fontana Medica Center

University of California, San Francisco-Fresno

Downtown L.A. Research Center, Inc.

L.A. Universal Research Center, INC.

Stanford

National Institute of Clinical Research, Inc

Paradigm Clinical Research

M3 Wake Research San Diego

FOMAT Medical Research - Central Coast Family Care

Med Partners, Inc.

Allianz Research Institute- Colorado

Paradigm Clinical Research Centers, LLC., Wheat Ridge

Yale University

Georgetown University Medical Center

Encore Medical Research of Boynton Beach, LLC

C & A Clinical trials Corp

Prestige Clinical Research Center Inc

Beautiful Minds Clinical Research Center

UHC Research, LLC

Dolphin Medical Research

Proactive Clinical Research, LLC

Evolution Clinical Trials

Aga Clinical Trials

Indago Research & Health Center, Inc.

Research In Miami, Inc.

Doral Medical Research, LLC

Sync, LLC

Jacksonville Center for Clinical Research

Health Awareness, LLC

Multi-Specialty Research Associates, Inc.

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

Clinical Site Partners LLC dba Flourish Research

Pro-Care Research Center

Essential Clinical Research, Inc

Southern Clinical Research, LLC

Angels Clinical Research Institute

LCC Medical Research Institute

CCM Clinical Research Group, LLC.

Retreat Medical Research

Clinical Trial Services, Corp

Continental Clinical Research, LLC

Dynamic Medical Research, LLC - Miami

Nuren Medical & Research Center

Advanced Care and Clinical Trials, LLC

Cordova Research Institute

Miami Clinical Research

Research Institute of South Florida, Inc.

P&S Research, LLC.

Pro Live Medical Research

Entrust Clinical Research

Links Clinical Trials LLC

Reed Medical Research

Nuovida Research Center, Corp

Oceanic Research Group

Palm Springs Community Health Center

USPA Advance Concept Medical Research Group. LLC

Angels Clinical Research Institute

Precision Research Center Inc

Santos Research Center

Palm Beach Research Center

Encore Medical Research of Weston

Agile Clinical Research Trials, LLC

Paradigm Clinical Research

Clinical Research Prime