Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-30 @ 6:03 PM
Study NCT ID:
NCT04721535
Status:
TERMINATED
Last Update Posted:
2022-12-07
First Post:
2021-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': "Termination of study due to sponsor's internal decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-04', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with COVID-19', 'timeFrame': 'Up to 14 days', 'description': 'positive result in RT-PCR test'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects with hospitalization', 'timeFrame': 'Days 3, 7, 14, and 28', 'description': 'hospitalization due to COVID-19'}, {'measure': 'Percentage of subjects who experience intensive care unit (ICU)', 'timeFrame': 'Days 3, 7, 14, and 28', 'description': 'ICU requirement due to COVID-19'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'SARS-COV-2 Infection']}, 'descriptionModule': {'briefSummary': 'To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over the age of 19 as of the signed date in written consent\n* Subjects in self-quarantine who contact from COVID-19 confirmed patient\n* Subjects who have COVID-19 negative RT-PCR result\n* Subjects with no symptoms of COVID-19\n\nExclusion Criteria:\n\n* Subjects who cannot orally administer the investigational products\n* Subjects who need administration of immunosuppressants\n* Subjects who are allergic or sensitive to investigational products or its ingredients\n* Subjects who have a history of drug and/or alcohol abuse within 12 months before screening\n* Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators'}, 'identificationModule': {'nctId': 'NCT04721535', 'briefTitle': 'A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2', 'orgStudyIdInfo': {'id': 'DW_DWJ1248303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWJ1248', 'description': 'Camostat mesilate 200mg', 'interventionNames': ['Drug: DWJ1248']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DWJ1248', 'type': 'DRUG', 'description': 'Orally, 1 tablet of DWJ1248 TID, up to 14 days', 'armGroupLabels': ['DWJ1248']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Orally, 1 tablet of placebo TID, up to 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}