Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 11:56 AM
Study NCT ID:
NCT04384250
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2020-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic and Immunologic Basis of COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059472', 'term': 'Exome'}], 'ancestors': [{'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-08', 'studyFirstSubmitDate': '2020-05-10', 'studyFirstSubmitQcDate': '2020-05-10', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mutations leading to increase susceptibility to SARS-COV-2 infection', 'timeFrame': '12 months', 'description': 'Genetic susceptibility to COVID-19'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-COV-2, Genetics'], 'conditions': ['Genetic Basis of COVID-19 Infection']}, 'descriptionModule': {'briefSummary': 'We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 positive patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe COVID-19 infection\n\nExclusion Criteria:\n\n* Comorbidity ((DM, hypertension, Chronic liver or Kidney diseases, HIV, morbid obesity, Malignancy, Immunosuppressive therapy)'}, 'identificationModule': {'nctId': 'NCT04384250', 'briefTitle': 'Genetic and Immunologic Basis of COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Genetic Factors Influencing the Response to Infection with SARS-COV-2', 'orgStudyIdInfo': {'id': 'RP:20.05.70'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Whole Exome Sequencing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Genetic study of patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlyia', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatric Immunology', 'investigatorFullName': 'Ali Sobh', 'investigatorAffiliation': 'Mansoura University'}}}}