Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT04404608
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2020-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etiology of Lymphopenia in Covid19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008231', 'term': 'Lymphopenia'}], 'ancestors': [{'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2020-05-23', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death or recovery', 'timeFrame': 'Up to 24 weeks', 'description': 'Follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphopenia']}, 'descriptionModule': {'briefSummary': 'Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients with severe illness and admitted to ICU. Third cohort will be patients critically ill and on artificial ventilation.', 'detailedDescription': 'Each cohort will include 30 patients. Complete blood count in all patients will be done daily in all patients. Bone marrow aspiration cytology will be done in some selected patients especially those with lymphopenia less than 1000 per cubic mm.\n\nCorrelation of the degree of lymphopenia with the status of the patients will be done. Also correlation will be done about the relation of recovery of lymphopenia and status of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted with the diagnosis off Covid19 viral infection of all ages and all ethnic backgrounds and agree about the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient admitted with the diagnosis of Covid19 viral infection\n\nExclusion Criteria:\n\n* Any patient who died within one day of admission'}, 'identificationModule': {'nctId': 'NCT04404608', 'briefTitle': 'Etiology of Lymphopenia in Covid19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Study of the Etiology of Lymphopenia in Covid19 Viral Infection', 'orgStudyIdInfo': {'id': '201920008.2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asymptomatic or mild symptoms patients patients', 'description': 'Patients with no or mild symptoms and need no respiratory support.', 'interventionNames': ['Diagnostic Test: Complete blood picture, bone marrow aspiration cytology']}, {'label': 'Severe symptoms patients', 'description': 'Patients who need admission to ICU because he needs oxygen by nasal canula and needs drugs whether azthromycin or remdesivir according to treatment protocol.', 'interventionNames': ['Diagnostic Test: Complete blood picture, bone marrow aspiration cytology']}, {'label': 'Critically ill patients', 'description': 'Patients who need artificial ventilation because of many causes and may need plasma from convalescent patients', 'interventionNames': ['Diagnostic Test: Complete blood picture, bone marrow aspiration cytology']}], 'interventions': [{'name': 'Complete blood picture, bone marrow aspiration cytology', 'type': 'DIAGNOSTIC_TEST', 'description': 'none except the regular routine investigations in such cases', 'armGroupLabels': ['Asymptomatic or mild symptoms patients patients', 'Critically ill patients', 'Severe symptoms patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Medhat Khafagy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor of surgical oncology', 'investigatorFullName': 'Dr Medhat Khafagy', 'investigatorAffiliation': 'Cairo University'}}}}