Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-28 @ 11:19 PM
Study NCT ID:
NCT05249803
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 months', 'description': 'The primary endpoint of the study will be to assess the ICU mortality (in percentages% and Numbers) of critically sick patients with COVID-19 pneumonia admitted to the intensive care unit'}], 'secondaryOutcomes': [{'measure': 'Comorbidities', 'timeFrame': '6 months', 'description': 'we will assess various comorbidities in critically sick patients with COVID-19 pneumonia admitted to the intensive care unit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Comorbidities', 'Outcomes', 'Covid-19'], 'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'COVID-19, caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), is a multisystem disease which primarily involves the respiratory tract. The first case of COVID-19 was identified in late 2019 in the province of Wuhan, China which was followed by the rapid spread of the disease globally, becoming a present-day pandemic.\n\nObjectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.', 'detailedDescription': 'Objectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.\n\nMaterial \\& Methods:\n\nStudy design: Retrospective study. Study Settings: Study was conducted in Fatima Memorial Hospital, Lahore. Study Duration: Study was conducted on Covid-19 patients who were admitted from March 2021 to August 2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-interventional retrospective cohort study of critically sick patients with COVID-19 pneumonia admitted in the Intensive Care Unit of Fatima Memorial hospital (FMH) in Lahore, Pakistan from March 2021 to August 2021 4.3. Sample Size \\& Technique: Records of 133 patients admitted to the ICU of the Fatima memorial hospital, Lahore, were studied.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically sick patients with COVID-19 Pneumonia\n* All admitted ICU patients with a diagnosis of COVID-19 pneumonia\n* Patients having positive reverse transcriptase PCR for COVID-19\n* Patients with High-resolution computed tomography (HRCT) chest findings suggestive of COVID-related lung injury\n* All patients above 16 years of age with both genders( males and females)\n\nExclusion Criteria:\n\n* All patients with PCR negative with mild symptoms\n* Patients with No signs of COVID-19 pneumonia on HRCT chest'}, 'identificationModule': {'nctId': 'NCT05249803', 'briefTitle': '"Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'FMH College of Medicine and Dentistry'}, 'officialTitle': '"Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19 Pneumonia Admitted in Intensive Care Unit of a Tertiary Care Hospital in Lahore, Pakistan": A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'FMH-27/12/2021-IRB-983'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COVID-19 pneumonia', 'description': 'These patients were admitted in ICU for management of Covid-19 pneumonia usual care was offered to all patients', 'interventionNames': ['Combination Product: Patients with COVID-19 Pneumonia']}], 'interventions': [{'name': 'Patients with COVID-19 Pneumonia', 'type': 'COMBINATION_PRODUCT', 'description': 'Patients were offered with usual care of COVID-19 in ICU and we did retrospective study', 'armGroupLabels': ['Patients with COVID-19 pneumonia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Fatima Memorial Hospital College of Medicine & Dentistry', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Aijaz Zeeshan K Chachar, MBBS,FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FMH College of Medicine & Dentistry'}]}, 'ipdSharingStatementModule': {'url': 'http://www.fatimamemorial.org.pk', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'All the record can be retrieved from medical record department of fatima memorial hospital Lahore'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FMH College of Medicine and Dentistry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Physician (Senior Registrar)', 'investigatorFullName': 'Aijaz Zeeshan Khan Chachar', 'investigatorAffiliation': 'FMH College of Medicine and Dentistry'}}}}