Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
Study NCT ID:
NCT04584606
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ain Shams University Experience: Clinical Determinants of Hospitalized COVID-19 Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-10', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-10', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery', 'timeFrame': 'Until patient is discharged or up to 12 weeks whichever comes first', 'description': 'Recovery defined as resolution of fever without the use of antipyretics, improvement of respiratory symptoms (e.g., cough, dyspnea) and no need for supplemental oxygen'}, {'measure': 'Mortality', 'timeFrame': 'Until patient is discharged or up to 12 weeks whichever comes first', 'description': 'All cause mortality'}], 'secondaryOutcomes': [{'measure': 'Conversion of nucleic acid testing for SARS-CoV-2 from positive to negative.', 'timeFrame': 'Until patient is discharged or up to 12 weeks whichever comes first', 'description': 'Detected by Polymerase Chain Reaction (PCR) test for nasopharyngeal swab'}, {'measure': 'Radiological progression of the COVID 19 disease', 'timeFrame': 'Until patient is discharged or up to 12 weeks whichever comes first', 'description': 'detected by measuring the extent of pulmonary lesion in high resolution computed tomography (HRCT) of the chest'}, {'measure': 'Functional progression of the COVID 19 disease', 'timeFrame': 'Until patient is discharged or up to 12 weeks whichever comes first', 'description': 'increase oxygen demands detected by arterial blood gases analysis and/or pulse oximeter'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Disease (COVID-19)']}, 'descriptionModule': {'briefSummary': "COVID-19 as a novel disease, different disease patterns were observed worldwide, and many treatment plans were tried. So, it is important to investigate the Egyptian clinical characteristics and different factors that determine the patient's 'outcome", 'detailedDescription': 'Investigators will convey the Ain Shams University experience as the first university in Egypt to designate one of its hospitals (Ain Shams University Obour Hospital) for management of confirmed COVID19 cases. investigators will try to identify the characteristics of the disease as regards the clinical, laboratory and imaging abnormalities and to assess the outcome determinants. It is a retrospective observational cohort study at Ain Shams University Obour Hospital. All adult patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2)will be included.\n\nClinical criteria, laboratory data, radiological findings, hospital course and patient outcome will be anonymously collected from records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).\n* Standard of care arm of the ongoing clinical trials will be included in our study.\n\nExclusion Criteria:\n\n* mild cases who don't need hospitalization"}, 'identificationModule': {'nctId': 'NCT04584606', 'briefTitle': 'Ain Shams University Experience: Clinical Determinants of Hospitalized COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Ain Shams University Experience: Clinical Characteristics and Outcome Determinants of Hospitalized Covid-19 Patients at Ain Shams University Obour Hospital', 'orgStudyIdInfo': {'id': 'FMASU P30/ 2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lab workup (on admission and regularly during follow up).', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['culture, imaging'], 'description': 'Complete blood count with differential leucocytic count. Absolute lymphocytic and neutrophilic count. Liver functions: Aspartate transaminase and Alanine transaminase . Renal functions: Blood urea nitrogen, serum Creatinine. HbA1C. C-reactive protein (quantitative). Serum ferritin level. D - dimer level (quantitative). Coagulation profile (Prothrombin time/ Partial thromboplastin time/ International normalized ratio).\n\nTroponin level. Arterial blood gases when needed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Non-US', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Fatma Soliman E Ebeid', 'role': 'CONTACT', 'email': 'dr.fatma_ebeid@yahoo.com', 'phone': '01095569596'}], 'facility': 'Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ashraf Elmaraghy', 'role': 'CONTACT', 'email': 'ashrafelmaraghy@yahoo.com', 'phone': '+20 100 177 0703'}], 'overallOfficials': [{'name': 'Ashraf Elmaraghy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University, Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ashraf A Elmaraghy', 'investigatorAffiliation': 'Ain Shams University'}}}}