Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 4:01 PM
Study NCT ID:
NCT06585150
Status:
TERMINATED
Last Update Posted:
2025-07-28
First Post:
2024-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'whyStopped': 'Study was terminated by Sponsor; the decision was not due to any safety findings.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-03', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) through Day 15', 'timeFrame': 'Day 1 up to Day 15', 'description': '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.'}, {'measure': 'Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Through Day 29', 'timeFrame': 'Up to 29 days'}, {'measure': 'Percentage of Participants Experiencing Laboratory Abnormalities Through Day 29', 'timeFrame': 'Up to 29 days'}, {'measure': 'Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation', 'timeFrame': 'First dose date up to Day 60'}], 'secondaryOutcomes': [{'measure': 'Time to Sustained Alleviation of Targeted RSV Symptoms as Measured by RiiQ Through Day 15', 'timeFrame': 'Day 1 up to Day 15', 'description': '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.'}, {'measure': 'Time to RSV-Related Lower Respiratory Tract Infection (LRTI) Through Day 29', 'timeFrame': 'Day 1 up to Day 29', 'description': '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.'}, {'measure': 'Time to RSV-Related Hospitalization or all-Cause Death Through Day 29', 'timeFrame': 'Day 1 up to Day 29', 'description': '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.'}, {'measure': 'Time to RSV-Related Medically Attended Visit (MAVs) or all-Cause Death Through Day 29', 'timeFrame': 'Day 1 up to Day 29'}, {'measure': 'Change from baseline in RSV Viral Load Through Day 3', 'timeFrame': 'Baseline, Day 3'}, {'measure': 'Change from Baseline in RSV Viral Load Through Day 5', 'timeFrame': 'Baseline, Day 5'}, {'measure': 'Change from Baseline in RSV Viral Load Through Day 7', 'timeFrame': 'Baseline, Day 7'}, {'measure': 'Change from Baseline in RSV Viral Load Through Day 10', 'timeFrame': 'Baseline, Day 10'}, {'measure': 'Change from Baseline in RSV Viral Load Through Day 15', 'timeFrame': 'Baseline, Day 15'}, {'measure': 'Pharmacokinetic (PK) Parameter: AUCtau of GS-441524', 'timeFrame': 'Day 1 to Day 5', 'description': 'AUCtau is defined as the area under the concentration versus time curve over the dosing interval.'}, {'measure': 'PK Parameter: Ctrough of GS-441524', 'timeFrame': 'Day 1 to Day 5', 'description': 'Ctrough is defined as the concentration at the end of the dosing interval'}, {'measure': 'PK Parameter: Cmax of GS-441524', 'timeFrame': 'Day 1 to Day 5', 'description': 'Cmax is defined as the maximum observed concentration of drug in plasma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['RSV Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT06585150', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Exhibits at least 1 of the following risk factors for severe RSV disease:\n\n 1. Age ≥ 60 years\n 2. Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.\n 3. Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months\n 4. One or more of the following chronic lung diseases:\n\n * i) Bronchiectasis\n * ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)\n * iii) Pulmonary hypertension\n 5. Chronic cardiovascular disease exclusive of hypertension\n* RSV infection confirmed ≤ 3 days before randomization\n* 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.\n* RSV vaccine status:\n\n * Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.\n\nKey Exclusion Criteria:\n\n* Currently requiring or expected to require hospitalization within 48 hours after randomization.\n* Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.\n* 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.\n* Concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization.\n* Individuals with a history of cystic fibrosis.\n* Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization.\n* Pregnant at screening.\n* 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.\n* Received an investigational product \\< 28 days or \\< 5 half-lives, whichever is longer, before randomization.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06585150', 'briefTitle': 'Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GS-US-685-6819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obeldesivir (ODV)', 'description': 'Participants will receive obeldesivir for 5 days', 'interventionNames': ['Drug: Obeldesivir']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo comparator: Obeldesivir Placebo', 'description': 'Participants will receive obeldesivir placebo for 5 days', 'interventionNames': ['Drug: Obeldesivir Placebo']}], 'interventions': [{'name': 'Obeldesivir', 'type': 'DRUG', 'otherNames': ['GS-5245'], 'description': 'Tablet administered orally', 'armGroupLabels': ['Obeldesivir (ODV)']}, {'name': 'Obeldesivir Placebo', 'type': 'DRUG', 'description': 'Tablet administered orally', 'armGroupLabels': ['Placebo comparator: Obeldesivir Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Alabama Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35055', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cullman Clinical Trials', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '35976', 'city': 'Guntersville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Lakeview Clinical Research, LLC', 'geoPoint': {'lat': 34.35823, 'lon': -86.29446}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Headlands Research-Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85378', 'city': 'Surprise', 'state': 'Arizona', 'country': 'United States', 'facility': 'Epic Medical Research-Surprise', 'geoPoint': {'lat': 33.63059, 'lon': -112.33322}}, {'zip': '91350', 'city': 'Canyon Country', 'state': 'California', 'country': 'United States', 'facility': 'Clearview Medical Research, LLC', 'geoPoint': {'lat': 34.42333, 'lon': -118.47203}}, {'zip': '92335', 'city': 'Fontana', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Fontana Medica Center', 'geoPoint': {'lat': 34.09223, 'lon': -117.43505}}, {'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco-Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Downtown L.A. Research Center, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'L.A. Universal Research Center, INC.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '91768', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'National Institute of Clinical Research, Inc', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '96001', 'city': 'Redding', 'state': 'California', 'country': 'United States', 'facility': 'Paradigm Clinical Research', 'geoPoint': {'lat': 40.58654, 'lon': -122.39168}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'M3 Wake Research San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'FOMAT Medical Research - Central Coast Family Care', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '91602', 'city': 'Toluca Lake', 'state': 'California', 'country': 'United States', 'facility': 'Med Partners, Inc.', 'geoPoint': {'lat': 34.15206, 'lon': -118.35719}}, {'zip': '80014', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Allianz Research Institute- Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Paradigm Clinical Research Centers, LLC., Wheat Ridge', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33436', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Encore Medical Research of Boynton Beach, LLC', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33990', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'facility': 'C & A Clinical trials Corp', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Prestige Clinical Research Center Inc', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33157', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Beautiful Minds Clinical Research Center', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, {'zip': '33126', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'UHC Research, LLC', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33172', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Dolphin Medical Research', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Proactive Clinical Research, LLC', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Aga Clinical Trials', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research & Health Center, Inc.', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33013', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Research In Miami, Inc.', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Doral Medical Research, LLC', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Sync, LLC', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Hialeah Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Evolution Clinical Trials', 'geoPoint': {'lat': 25.8651, 'lon': -80.3245}}, {'zip': '32217', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Health Awareness, LLC', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '32055', 'city': 'Lake City', 'state': 'Florida', 'country': 'United States', 'facility': 'Multi-Specialty Research Associates, Inc.', 'geoPoint': {'lat': 30.18968, 'lon': -82.63929}}, {'zip': '33777', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Research Sites - 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