Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-05 @ 5:48 PM
Study NCT ID:
NCT04757792
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2021-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 475}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2021-02-11', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '6 months', 'description': 'number of patients who were died secondary to COVID-19 disease or its complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'NSAID', 'Aspirin', 'Mortality'], 'conditions': ['COVID-19 Disease']}, 'descriptionModule': {'briefSummary': 'Retrospective multicenter study to evaluate the data of COVID-19 patients who were admitted to university hospitals in relation to their recent administration or maintenance on non-steroidal anti-inflammatory drugs (NSAID) prior to have COVID-19 disease and to analyze it in relation to outcome of these patients.', 'detailedDescription': 'The data contained in hospital registry were collected, categorized into demographic, previous medical history, the use of NSAID as maintenance therapy or its recent administration before diagnosis of COVID-19 disease, presenting manifestations, laboratory and CT findings, applied therapies or interventions. Outcomes will be categorized as survival and non-survival outcome. Survivors will be subdivided as complete recovery or recovery with getting new morbidities. Mortality was subdivided as total hospital and ICU mortality. Data will be statistically analyzed in relation to outcomes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with diagnosis of COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* assured diagnosis of COVID-19 by RT-PCR\n\nExclusion Criteria:\n\n* No'}, 'identificationModule': {'nctId': 'NCT04757792', 'briefTitle': 'Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU', 'orgStudyIdInfo': {'id': 'RC1-2-2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No NSAID', 'description': 'included patients who did not receive NSAID prior to having COVID-19 disease', 'interventionNames': ['Other: File inquiry']}, {'label': 'Apsirin', 'description': 'included patients who received acetylsalicylic acid (ASA) prior to having COVID-19 disease', 'interventionNames': ['Other: File inquiry']}, {'label': 'Celecoxib', 'description': 'included patients who received celecoxib (CEL) prior to having COVID-19 disease', 'interventionNames': ['Other: File inquiry']}, {'label': 'Miscellaneous', 'description': 'included patients who received miscellaneous NSAID other than ASA or CEL prior to having COVID-19 disease', 'interventionNames': ['Other: File inquiry']}], 'interventions': [{'name': 'File inquiry', 'type': 'OTHER', 'otherNames': ['No interventions'], 'description': 'Data extraction out of file registry', 'armGroupLabels': ['Apsirin', 'Celecoxib', 'Miscellaneous', 'No NSAID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0013', 'city': 'Banhā', 'state': 'Qalyubia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Adel Alkholy, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine, Banha University, Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publishing', 'ipdSharing': 'YES', 'description': 'Protocol data will be available on request', 'accessCriteria': 'email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}, {'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medical Biochemistry', 'investigatorFullName': 'Adel F. Alkholy', 'investigatorAffiliation': 'Benha University'}}}}