Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
- Registration Number
- NCT06585150
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
-
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 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.
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obeldesivir (ODV) Obeldesivir Participants will receive obeldesivir for 5 days Placebo comparator: Obeldesivir Placebo Obeldesivir Placebo Participants will receive obeldesivir placebo for 5 days
- Primary Outcome Measures
Name Time Method Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Through Day 29 Up to 29 days Percentage of Participants Experiencing Laboratory Abnormalities Through Day 29 Up to 29 days Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) through Day 15 Day 1 up to Day 15 The RiiQ symptom scale is a 13-item questionnaire rated on a 4-point scale. Each symptom is rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity.
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation First dose date up to Day 60
- Secondary Outcome Measures
Name Time Method Time to Sustained Alleviation of Targeted RSV Symptoms as Measured by RiiQ Through Day 15 Day 1 up to Day 15 The RiiQ symptom scale is a 13-item questionnaire rated on a 4-point scale. Each symptom is rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity.
Time to RSV-Related Lower Respiratory Tract Infection (LRTI) Through Day 29 Day 1 up to Day 29 RSV-related LRTI will be defined by symptoms (eg, cough, shortness of breath, wheezing, expectoration \[coughing up mucus\]) as assessed by the RiiQ symptom scale.
Time to RSV-Related Hospitalization or all-Cause Death Through Day 29 Day 1 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.
Time to RSV-Related Medically Attended Visit (MAVs) or all-Cause Death Through Day 29 Day 1 up to Day 29 Change from baseline in RSV Viral Load Through Day 3 Baseline, Day 3 Change from Baseline in RSV Viral Load Through Day 5 Baseline, Day 5 Change from Baseline in RSV Viral Load Through Day 7 Baseline, Day 7 Change from Baseline in RSV Viral Load Through Day 10 Baseline, Day 10 Change from Baseline in RSV Viral Load Through Day 15 Baseline, Day 15 Pharmacokinetic (PK) Parameter: AUCtau of GS-441524 Day 1 to Day 5 AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
PK Parameter: Ctrough of GS-441524 Day 1 to Day 5 Ctrough is defined as the concentration at the end of the dosing interval
PK Parameter: Cmax of GS-441524 Day 1 to Day 5 Cmax is defined as the maximum observed concentration of drug in plasma.
Trial Locations
- Locations (117)
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
Lakeview Clinical Research, LLC
🇺🇸Guntersville, Alabama, United States
Headlands Research-Scottsdale
🇺🇸Scottsdale, Arizona, United States
Epic Medical Research-Surprise
🇺🇸Surprise, Arizona, United States
Clearview Medical Research, LLC
🇺🇸Canyon Country, California, United States
Kaiser Permanente Fontana Medica Center
🇺🇸Fontana, California, United States
University of California, San Francisco-Fresno
🇺🇸Fresno, California, United States
Downtown L.A. Research Center, Inc.
🇺🇸Los Angeles, California, United States
L.A. Universal Research Center, INC.
🇺🇸Los Angeles, California, United States
Stanford
🇺🇸Palo Alto, California, United States
National Institute of Clinical Research, Inc
🇺🇸Pomona, California, United States
Paradigm Clinical Research
🇺🇸Boise, Idaho, United States
M3 Wake Research San Diego
🇺🇸San Diego, California, United States
FOMAT Medical Research - Central Coast Family Care
🇺🇸Santa Maria, California, United States
Med Partners, Inc.
🇺🇸Toluca Lake, California, United States
Allianz Research Institute- Colorado
🇺🇸Aurora, Colorado, United States
Paradigm Clinical Research Centers, LLC., Wheat Ridge
🇺🇸Wheat Ridge, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Encore Medical Research of Boynton Beach, LLC
🇺🇸Boynton Beach, Florida, United States
C & A Clinical trials Corp
🇺🇸Cape Coral, Florida, United States
Prestige Clinical Research Center Inc
🇺🇸Coral Gables, Florida, United States
Beautiful Minds Clinical Research Center
🇺🇸Cutler Bay, Florida, United States
UHC Research, LLC
🇺🇸Doral, Florida, United States
Dolphin Medical Research
🇺🇸Doral, Florida, United States
Proactive Clinical Research, LLC
🇺🇸Fort Lauderdale, Florida, United States
Evolution Clinical Trials
🇺🇸Hialeah Gardens, Florida, United States
Aga Clinical Trials
🇺🇸Hialeah, Florida, United States
Indago Research & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Research In Miami, Inc.
🇺🇸Hialeah, Florida, United States
Doral Medical Research, LLC
🇺🇸Hialeah, Florida, United States
Sync, LLC
🇺🇸Hialeah, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Health Awareness, LLC
🇺🇸Jupiter, Florida, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
Accel Research Sites - St. Pete-Largo Clinical Research Unit
🇺🇸Largo, Florida, United States
Clinical Site Partners LLC dba Flourish Research
🇺🇸Leesburg, Florida, United States
Pro-Care Research Center
🇺🇸Miami Gardens, Florida, United States
Essential Clinical Research, Inc
🇺🇸Miami Lakes, Florida, United States
Southern Clinical Research, LLC
🇺🇸Miami Lakes, Florida, United States
Angels Clinical Research Institute
🇺🇸Tampa, Florida, United States
LCC Medical Research Institute
🇺🇸Miami, Florida, United States
CCM Clinical Research Group, LLC.
🇺🇸Miami, Florida, United States
Retreat Medical Research
🇺🇸Miami, Florida, United States
Clinical Trial Services, Corp
🇺🇸Miami, Florida, United States
Continental Clinical Research, LLC
🇺🇸Miami, Florida, United States
Dynamic Medical Research, LLC - Miami
🇺🇸Miami, Florida, United States
Nuren Medical & Research Center
🇺🇸Miami, Florida, United States
Advanced Care and Clinical Trials, LLC
🇺🇸Miami, Florida, United States
Cordova Research Institute
🇺🇸Miami, Florida, United States
Miami Clinical Research
🇺🇸Miami, Florida, United States
Research Institute of South Florida, Inc.
🇺🇸Miami, Florida, United States
P&S Research, LLC.
🇺🇸Miami, Florida, United States
Pro Live Medical Research
🇺🇸Miami, Florida, United States
Entrust Clinical Research
🇺🇸Miami, Florida, United States
Links Clinical Trials LLC
🇺🇸Miami, Florida, United States
Reed Medical Research
🇺🇸Miami, Florida, United States
Nuovida Research Center, Corp
🇺🇸Miami, Florida, United States
Oceanic Research Group
🇺🇸North Miami Beach, Florida, United States
Palm Springs Community Health Center
🇺🇸Palm Springs, Florida, United States
USPA Advance Concept Medical Research Group. LLC
🇺🇸South Miami, Florida, United States
Precision Research Center Inc
🇺🇸Tampa, Florida, United States
Santos Research Center
🇺🇸Tampa, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Encore Medical Research of Weston
🇺🇸Weston, Florida, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Metro Infectious Disease Consultants
🇺🇸Burr Ridge, Illinois, United States
Endeavor Health - Clinical Trials Center
🇺🇸Skokie, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Tranquil Clinical Research
🇺🇸Webster, Iowa, United States
CCT Research- Versailles Family Medicine
🇺🇸Versailles, Kentucky, United States
Centennial Medical Group
🇺🇸Columbia, Maryland, United States
Great Lakes Research Institute
🇺🇸Southfield, Michigan, United States
Javara Inc.
🇺🇸Mankato, Minnesota, United States
University of Minnesota
🇺🇸Saint Paul, Minnesota, United States
Hannibal Regional Healthcare System, Inc
🇺🇸Hannibal, Missouri, United States
Clay-Platte Family Medicine/Avacare
🇺🇸Kansas City, Missouri, United States
Velocity Clinical Research
🇺🇸Norfolk, Nebraska, United States
Be Well Clinical Studies
🇺🇸Lincoln, Nebraska, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
NYC Health and Hospitals-Lincoln
🇺🇸Bronx, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Prime Global Research, Inc.
🇺🇸New York, New York, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Eximia Research-NC, LLC
🇺🇸Raleigh, North Carolina, United States
Wake Research
🇺🇸Raleigh, North Carolina, United States
Trial Management Associates, LLC
🇺🇸Wilmington, North Carolina, United States
The Lidner Research Center at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Epic Medical Research- Oklahoma
🇺🇸Chickasha, Oklahoma, United States
Velocity Clinical Research - Anderson
🇺🇸Anderson, South Carolina, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
PanAmerican Clinical Research, LLC
🇺🇸Brownsville, Texas, United States
Epic Medical Research-Carrollton
🇺🇸Carrollton, Texas, United States
WR- Global Medical Research, LLC
🇺🇸Dallas, Texas, United States
Vilo Research Group, Inc
🇺🇸Houston, Texas, United States
C & R Research Services USA, Inc.
🇺🇸Houston, Texas, United States
Diversified Medical Practices
🇺🇸Houston, Texas, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Santa Clara Family Clinic
🇺🇸Houston, Texas, United States
Next Level Urgent Care
🇺🇸Houston, Texas, United States
The Crofoot Research Center, INC.
🇺🇸Houston, Texas, United States
Helios Clinical Keller
🇺🇸Keller, Texas, United States
Andres Garcia-Zuniga, MD, PA
🇺🇸Laredo, Texas, United States
Metroplex Pulmonary and Sleep Center
🇺🇸McKinney, Texas, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Epic Medical Research LLC - DeSoto
🇺🇸Red Oak, Texas, United States
Medrasa Clinical Research
🇺🇸Sherman, Texas, United States
Velocity Clinical Research-Salt Lake City
🇺🇸West Jordan, Utah, United States
Velocity Clinical Research- Suffolk
🇺🇸Portsmouth, Virginia, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
Swedish Organ transplant and Liver Center
🇺🇸Seattle, Washington, United States
Frontier Clinical Research. LLC Kingwood
🇺🇸Kingwood, West Virginia, United States
Frontier Clinical Research, LLC
🇺🇸Morgantown, West Virginia, United States