OVERVIEW
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
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
RSV Infection
Gender
N/A
Date
October 2024 - May 2025
Study Type
Interventional
Study Phase
Phase 2
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 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.
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
Locations (121)
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
National Institute of Clinical Research, Inc
Pomona, California, United States, 91768
M3 Wake Research San Diego
San Diego, California, United States, 92111
FOMAT Medical Research - Central Coast Family Care
Santa Maria, California, United States, 93454
Allianz Research Institute- Colorado
Aurora, Colorado, United States, 80014
Paradigm Clinical Research Centers, LLC., Wheat Ridge
Wheat Ridge, Colorado, United States, 80033
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Encore Medical Research of Boynton Beach, LLC
Boynton Beach, Florida, United States, 33436
Prestige Clinical Research Center Inc
Coral Gables, Florida, United States, 33134
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States, 33157
Proactive Clinical Research, LLC
Fort Lauderdale, Florida, United States, 33308
Indago Research & Health Center, Inc.
Hialeah, Florida, United States, 33012
Evolution Clinical Trials
Hialeah Gardens, Florida, United States, 33016
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32217
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
Angels Clinical Research Institute
Miami, Florida, United States, 33122
CCM Clinical Research Group, LLC.
Miami, Florida, United States, 33133
Continental Clinical Research, LLC
Miami, Florida, United States, 33144
Dynamic Medical Research, LLC - Miami
Miami, Florida, United States, 33144
Advanced Care and Clinical Trials, LLC
Miami, Florida, United States, 33155
Research Institute of South Florida, Inc.
Miami, Florida, United States, 33173
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
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
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
Metro Infectious Disease Consultants
Burr Ridge, Illinois, United States, 60527
Endeavor Health - Clinical Trials Center
Skokie, Illinois, United States, 60077
CCT Research- Versailles Family Medicine
Versailles, Kentucky, United States, 40383
Great Lakes Research Institute
Southfield, Michigan, United States, 48075
Hannibal Regional Healthcare System, Inc
Hannibal, Missouri, United States, 63401
Clay-Platte Family Medicine/Avacare
Kansas City, Missouri, United States, 64151
Clinical Research of South Nevada
Las Vegas, Nevada, United States, 89121
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
NYC Health and Hospitals-Lincoln
The Bronx, New York, United States, 10451
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Eximia Research-NC, LLC
Raleigh, North Carolina, United States, 27607
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
PanAmerican Clinical Research, LLC
Brownsville, Texas, United States, 78520
Epic Medical Research-Carrollton
Carrollton, Texas, United States, 75006
C & R Research Services USA, Inc.
Houston, Texas, United States, 77022
The Crofoot Research Center, INC.
Houston, Texas, United States, 77098
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States, 75069
Epic Medical Research LLC - DeSoto
Red Oak, Texas, United States, 75154
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
Join Gilead Trial Connect and help advance clinical research. Your participation is key to developing future treatments.
Share Trial