Ignite Creation Date:
2025-12-25 @ 4:38 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT04434118
Status:
WITHDRAWN
Last Update Posted:
2022-05-09
First Post:
2020-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Institutional Issue', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2020-06-13', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The risk of COVID-19 infection among RA patients', 'timeFrame': '12 week', 'description': 'Realtion between hydroxychloroquine use and COVID-19 infection'}], 'secondaryOutcomes': [{'measure': 'The incidence of hospitalization for Covid-19 patients.', 'timeFrame': '12 week', 'description': 'Number of cases and number of hospitalization days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'COVID']}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients fulfilling 2010 ACR-EULAR classification criteria for RA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Data of all definite cases of RA were collected and reviewed from complete medical records of patients by a team that included 2 trained physicians using a pretested data collection form.\n\nExclusion Criteria:\n\n* The exclusion criteria were included incomplete medical records or those with difficulty to communicate with the patients.\n* Patients with acute lethal organ injury (e.g., acute myocardial infarction, acute coronary syndrome, acute pulmonary embolism, or acute stroke)\n* Patients with decompensated or end stage chronic organ dysfunction (e.g., decompensated cirrhosis, decompensated chronic renal insufficiency, or severe congestive heart failure), diabetes mellitus, data of pregnant females, acquired immune deficiency syndrome (aids), and leukemia or other malignancies.'}, 'identificationModule': {'nctId': 'NCT04434118', 'briefTitle': 'Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sadat City University'}, 'officialTitle': 'Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study', 'orgStudyIdInfo': {'id': 'IRB: RC-5-2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid Arthritis with COVID-19', 'interventionNames': ['Drug: Traditional antirheumatic drugs']}, {'label': 'Rheumatoid Arthritis without COVID-19', 'interventionNames': ['Drug: Traditional antirheumatic drugs']}], 'interventions': [{'name': 'Traditional antirheumatic drugs', 'type': 'DRUG', 'description': 'Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine', 'armGroupLabels': ['Rheumatoid Arthritis with COVID-19', 'Rheumatoid Arthritis without COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shibīn al Kawm', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sadat City University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy, PhD.', 'investigatorFullName': 'Mahmoud Samy Abdallah', 'investigatorAffiliation': 'Sadat City University'}}}}