RSV InfectionPhase 2NCT06585150
Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
A Phase 2 study testing Obeldesivir in people with RSV Infection, run by Gilead Sciences at 121 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RSV Infection
- What is being tested?
- Obeldesivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 121 sitesUnited States
- Study dates
- 14 Oct 2024to 9 Jun 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
121 sites in 1 country.
121 sites in 1 country
United States121 sites
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328
Allianz Research Institute- Colorado
Aurora, Colorado, 80014
Central Texas Clinical Research
Austin, Texas, 78705
Inquest Clinical Research
Baytown, Texas, 77521
Central Alabama Research
Birmingham, Alabama, 35209
Paradigm Clinical Research
Boise, Idaho, 83709
Encore Medical Research of Boynton Beach, LLC
Boynton Beach, Florida, 33436
PanAmerican Clinical Research, LLC
Brownsville, Texas, 78520
Metro Infectious Disease Consultants
Burr Ridge, Illinois, 60527
Clearview Medical Research, LLC
Canyon Country, California, 91350
C & A Clinical trials Corp
Cape Coral, Florida, 33990
Epic Medical Research-Carrollton
Carrollton, Texas, 75006
Epic Medical Research- Oklahoma
Chickasha, Oklahoma, 73018
The Lidner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
Centennial Medical Group
Columbia, Maryland, 21045
Prestige Clinical Research Center Inc
Coral Gables, Florida, 33134
Cullman Clinical Trials
Cullman, Alabama, 35055
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, 33157
WR- Global Medical Research, LLC
Dallas, Texas, 75224
UHC Research, LLC
Doral, Florida, 33126
Dolphin Medical Research
Doral, Florida, 33172
Providence Regional Medical Center Everett
Everett, Washington, 98201
Kaiser Permanente Fontana Medica Center
Fontana, California, 92335
Proactive Clinical Research, LLC
Fort Lauderdale, Florida, 33308
University of California, San Francisco-Fresno
Fresno, California, 93701
Lakeview Clinical Research, LLC
Guntersville, Alabama, 35976
Hannibal Regional Healthcare System, Inc
Hannibal, Missouri, 63401
Aga Clinical Trials
Hialeah, Florida, 33012
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012
Research In Miami, Inc.
Hialeah, Florida, 33013
Doral Medical Research, LLC
Hialeah, Florida, 33016
Sync, LLC
Hialeah, Florida, 33016
Evolution Clinical Trials
Hialeah Gardens, Florida, 33016
Vilo Research Group, Inc
Houston, Texas, 77017
C & R Research Services USA, Inc.
Houston, Texas, 77022
Diversified Medical Practices
Houston, Texas, 77057
Clinical Trial Network
Houston, Texas, 77074
Santa Clara Family Clinic
Houston, Texas, 77087
Next Level Urgent Care
Houston, Texas, 77095
The Crofoot Research Center, INC.
Houston, Texas, 77098
Clinical Research Prime
Idaho Falls, Idaho, 83404
University of Iowa
Iowa City, Iowa, 52242
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32217
Health Awareness, LLC
Jupiter, Florida, 33458
Clay-Platte Family Medicine/Avacare
Kansas City, Missouri, 64151
Helios Clinical Keller
Keller, Texas, 76248
Frontier Clinical Research. LLC Kingwood
Kingwood, West Virginia, 26537
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055
Andres Garcia-Zuniga, MD, PA
Laredo, Texas, 78041
Accel Research Sites - St. Pete-Largo Clinical Research Unit
Largo, Florida, 33777
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
Clinical Site Partners LLC dba Flourish Research
Leesburg, Florida, 34748
Velocity Clinical Research
Lincoln, Nebraska, 68510
Velocity Clinical Research
Lincoln, Nebraska, 68516
Be Well Clinical Studies
Lincoln, Nebraska, 78681
Downtown L.A. Research Center, Inc.
Los Angeles, California, 90017
L.A. Universal Research Center, INC.
Los Angeles, California, 90057
Javara Inc.
Mankato, Minnesota, 56001
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069
SMS Clinical Research
Mesquite, Texas, 75149
Angels Clinical Research Institute
Miami, Florida, 33122
LCC Medical Research Institute
Miami, Florida, 33126
CCM Clinical Research Group, LLC.
Miami, Florida, 33133
Retreat Medical Research
Miami, Florida, 33135
Clinical Trial Services, Corp
Miami, Florida, 33144
Continental Clinical Research, LLC
Miami, Florida, 33144
Dynamic Medical Research, LLC - Miami
Miami, Florida, 33144
Nuren Medical & Research Center
Miami, Florida, 33144
Advanced Care and Clinical Trials, LLC
Miami, Florida, 33155
Cordova Research Institute
Miami, Florida, 33155
Miami Clinical Research
Miami, Florida, 33155
Research Institute of South Florida, Inc.
Miami, Florida, 33173
P&S Research, LLC.
Miami, Florida, 33175
Pro Live Medical Research
Miami, Florida, 33175
Entrust Clinical Research
Miami, Florida, 33176
Links Clinical Trials LLC
Miami, Florida, 33176
Reed Medical Research
Miami, Florida, 33176
Nuovida Research Center, Corp
Miami, Florida, 33186
Pro-Care Research Center
Miami Gardens, Florida, 33014
Essential Clinical Research, Inc
Miami Lakes, Florida, 33014
Southern Clinical Research, LLC
Miami Lakes, Florida, 33014
Monroe Biomedical Research
Monroe, North Carolina, 28112
Frontier Clinical Research, LLC
Morgantown, West Virginia, 26501
Yale University
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Weill Cornell Medicine
New York, New York, 10065
Prime Global Research, Inc.
New York, New York, 10456
Velocity Clinical Research
Norfolk, Nebraska, 68701
Oceanic Research Group
North Miami Beach, Florida, 33169
Palm Springs Community Health Center
Palm Springs, Florida, 92262
Stanford
Palo Alto, California, 94304
National Institute of Clinical Research, Inc
Pomona, California, 91768
Velocity Clinical Research- Suffolk
Portsmouth, Virginia, 23703
Eximia Research-NC, LLC
Raleigh, North Carolina, 27607
Wake Research
Raleigh, North Carolina, 27612
Epic Medical Research LLC - DeSoto
Red Oak, Texas, 75154
Paradigm Clinical Research
Redding, California, 96001
University of Minnesota
Saint Paul, Minnesota, 55102
M3 Wake Research San Diego
San Diego, California, 92111
FOMAT Medical Research - Central Coast Family Care
Santa Maria, California, 93454
Headlands Research-Scottsdale
Scottsdale, Arizona, 85260
Swedish Organ transplant and Liver Center
Seattle, Washington, 98122
Medrasa Clinical Research
Sherman, Texas, 75092
Endeavor Health - Clinical Trials Center
Skokie, Illinois, 60077
USPA Advance Concept Medical Research Group. LLC
South Miami, Florida, 33143
Great Lakes Research Institute
Southfield, Michigan, 48075
Epic Medical Research-Surprise
Surprise, Arizona, 85378
Angels Clinical Research Institute
Tampa, Florida, 33614
Precision Research Center Inc
Tampa, Florida, 33614
Santos Research Center
Tampa, Florida, 33615
NYC Health and Hospitals-Lincoln
The Bronx, New York, 10451
Med Partners, Inc.
Toluca Lake, California, 91602
CCT Research- Versailles Family Medicine
Versailles, Kentucky, 40383
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Tranquil Clinical Research
Webster, Iowa, 77598
Velocity Clinical Research-Salt Lake City
West Jordan, Utah, 84088
Palm Beach Research Center
West Palm Beach, Florida, 33409
Encore Medical Research of Weston
Weston, Florida, 33331
Paradigm Clinical Research Centers, LLC., Wheat Ridge
Wheat Ridge, Colorado, 80033
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
About this study
Official title: 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.
- Conditions
- RSV Infection
- Being tested
- Obeldesivir, Obeldesivir Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObeldesivirDrug
Also called GS-5245
Tablet administered orally
Obeldesivir PlaceboDrug
Tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Obeldesivir | Experimental | Participants will receive ODV 700 mg twice on Day 1, followed by ODV 350 mg twice daily on Days 2 to 5. Receives: Drug: Obeldesivir |
| Placebo | Experimental | Participants will receive placebo-to-match (PTM) ODV twice daily for 5 days. Receives: Drug: Obeldesivir Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Up to Day 15
Time to RSV-Related Lower Respiratory Tract Infection (LRTI) Through 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.
Measured: Up to Day 29
Time to RSV-Related Hospitalization or All-Cause Death Through 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.
Measured: Up to Day 29
Time to RSV-Related Medically Attended Visit or All-Cause Death Through 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.
Measured: Up to Day 29
RSV Viral Load At Baseline
The RSV viral load results were obtained from UTM (universal transport medium) nasal swab samples collected at Baseline.
Measured: Baseline
Change From Baseline in RSV Viral Load Through Day 3
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 3.
Measured: Baseline, Day 3
Change From Baseline in RSV Viral Load Through Day 5
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 5.
Measured: Baseline, Day 5
Change From Baseline in RSV Viral Load Through Day 7
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 7.
Measured: Baseline, Day 7
Change From Baseline in RSV Viral Load Through Day 10
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 10.
Measured: Baseline, Day 10
Change From Baseline in RSV Viral Load Through Day 15
The RSV viral load results were obtained from UTM nasal swab samples collected at Baseline and Day 15.
Measured: Baseline, Day 15
Pharmacokinetic (PK) Parameter: AUCtau of GS-441524, Metabolite of Obeldesivir
AUCtau is defined as area under the plasma concentration-time curve during a dosing interval.
Measured: Day 5: Pre-dose and at multiple timepoints (up to 12 hours) post-dose
PK Parameter: Ctrough of GS-441524, Metabolite of Obeldesivir
Ctrough is defined as the concentration at the end of the dosing interval.
Measured: Day 5 (predose)
PK Parameter: Cmax of GS-441524, Metabolite of Obeldesivir
Cmax is defined as the maximum observed concentration of drug in plasma.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start14 Oct 2024
- Primary completion8 May 2025
- Study completion9 Jun 2025
Why it stopped: Study was terminated by Sponsor; the decision was not due to any safety findings.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585150
- Sponsor's protocol ID
- GS-US-685-6819
- Status last verified
- Jun 2026
- First submitted
- 3 Sep 2024
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No