Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT05568706
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2022-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Israel', 'Netherlands', 'Philippines', 'Puerto Rico']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723099', 'term': 'EDP-938'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms', 'timeFrame': 'Day 1 through Day 33'}], 'secondaryOutcomes': [{'measure': 'Time to resolution of LRTD symptoms and 2 systemic symptoms', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Time to resolution of all RSV symptoms', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Change from Baseline in severity of RSV LRTD symptoms', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Change from Baseline for impact scale', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Time to resolution of Upper Respiratory Tract Disease congestion), LRTD, and 2 systemic symptoms', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Time to no or mild impact of RSV disease on daily activities, emotions, and social relationships', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Percentage of participants with post-baseline RSV-related complications', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Time to improvement in RSV disease', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Change from Baseline for Health-Related Quality of Life', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Time to return to usual health', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Time to return to usual activities', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Percentage of subjects requiring hospitalization for RSV or other causes;', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'Duration of hospitalization for RSV or other causes', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'All-cause mortality', 'timeFrame': 'Day 1 through Day 33'}, {'measure': 'RSV RNA viral load change from Baseline', 'timeFrame': 'Days 3, 5, 9, and 14'}, {'measure': 'Change in infectious RSV viral load over time', 'timeFrame': 'Up to Day 14'}, {'measure': 'Plasma PK Concentrations of EDP-938', 'timeFrame': 'Up to Day 5'}, {'measure': 'Safety as measured by frequency of adverse events (AEs)', 'timeFrame': 'Up to Day 33'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Risk, Respiratory Syncytial Virus'], 'conditions': ['RSV Infection']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who are at high risk for complications after RSV infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least one of the following conditions that predispose them to complications after RSV infection:\n\n 1. Age ≥65 years\n 2. Congestive heart failure (CHF)\n 3. Asthma\n 4. Chronic obstructive pulmonary disease (COPD)\n* The subject has a new onset of any of the following symptom(s) or worsening of pre-existing symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath.\n* The subject reports at least 2 of the following symptoms, one of which must be reported as at least 'moderate' severity: cough, cough with phlegm, wheezing, or short of breath\n* The subject has tested positive for RSV infection using a NAAT (polymerase chain reaction \\[PCR\\] or other) on a nasal/nasopharyngeal swab sample.\n* A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.\n* A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.\n\nExclusion Criteria:\n\n* The subject has an anticipated need for hospitalization within 24 hours of signing the Study ICF\n* The subject receives systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days prior to signing the Study ICF\n* The subject has concomitant respiratory infections that are viral (other than RSV but including influenza), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days prior to signing the Study ICF\n* The subject has a SARS-CoV-2 test result that is positive within 28 days prior to signing the Study ICF\n* The subject has COPD with spirometry results (obtained within 1 year prior to signing the Study ICF) FEV1 ≤35%\n* The subject has a known positive human immunodeficiency virus infection, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current hepatitis C virus (HCV) infection; subjects with a history of HCV infection who have achieved a documented sustained virologic response 12 weeks after completion of HCV therapy may be enrolled.\n* The subject has any of the following cardiac conditions: any congenital heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation\n* The subject has immunocompromised status\n* The subject is living in institutional care or assisted living facility and is also receiving acute care management for any respiratory condition; Note: Independent living apartments are not considered institutional care or assisted living facility"}, 'identificationModule': {'nctId': 'NCT05568706', 'acronym': 'RSVHR', 'briefTitle': 'A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enanta Pharmaceuticals, Inc'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults With Acute Respiratory Syncytial Virus Infection Who Are at High Risk for Complications', 'orgStudyIdInfo': {'id': 'EDP 938-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EDP-938', 'description': 'EDP-938 800 mg, once daily', 'interventionNames': ['Drug: EDP-938']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo, once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EDP-938', 'type': 'DRUG', 'description': 'Subjects will take EDP-938 once daily for 5 days', 'armGroupLabels': ['EDP-938']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will take matching placebo, once daily for 5 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85282-2455', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Voyage Medical', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research Institute', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Downtown LA Research Center Inc - 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H. 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