Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-29 @ 1:24 AM
Study NCT ID:
NCT04479293
Status:
UNKNOWN
Last Update Posted:
2020-09-09
First Post:
2020-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post COVID-19 Functional Status in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D020447', 'term': 'Parasomnias'}], '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'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-07', 'studyFirstSubmitDate': '2020-07-19', 'studyFirstSubmitQcDate': '2020-07-19', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of functional limitations post COVID-19', 'timeFrame': '3-6 month', 'description': 'scale 0-64 points'}], 'secondaryOutcomes': [{'measure': 'number of psychologic changes', 'timeFrame': '3-6 months', 'description': 'Hamilton scale, points'}, {'measure': 'Sleep Disturbance and quality', 'timeFrame': '3-6 months', 'description': 'ESS scale 0-20, points'}, {'measure': 'Radiologic changes', 'timeFrame': '3-6 months', 'description': 'Chest HRCT'}, {'measure': 'Laboratory changes', 'timeFrame': '3-6 moths', 'description': 'Complete blood count, C - reactive protein, serum ferritin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional score', 'Radiologic changes', 'Psychologic changes', 'Laboratory', 'Sleep disturbance'], 'conditions': ['COVID-19', 'Coronavirus Disease', 'SARS-CoV-2']}, 'descriptionModule': {'briefSummary': 'Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed as COVID-19 on clinical, laboratory, radiologic or PCR based are included.\n\nPatients with different severity mild, moderate, severe , managed at home or in hospitals are included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All confirmed cases with COVID-19\n\nExclusion Criteria:\n\n* Non COVID-19 cases'}, 'identificationModule': {'nctId': 'NCT04479293', 'briefTitle': 'Post COVID-19 Functional Status in Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Functional Recovery From COVID-19 Using the Proposed Post- COVID-19 Functional Status Score', 'orgStudyIdInfo': {'id': 'AssiutU16'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Post COVID-19 Functional Satus Scale', 'type': 'OTHER', 'description': 'scale from 0-64 assessing functional limitation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Aliaa AR Hussein', 'role': 'CONTACT', 'email': 'aliaehussein@aun.edu.eg', 'phone': '+201222302352'}], 'facility': 'Aliaa Hussein', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Aliae Mohamed-Hussein', 'role': 'CONTACT', 'email': 'aliaehussein@aun.edu.eg', 'phone': '01222302352'}], 'overallOfficials': [{'name': 'Aliae Mohamed-Hussein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pulmonology', 'investigatorFullName': 'Aliae AR Mohamed Hussein', 'investigatorAffiliation': 'Assiut University'}}}}