Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-31 @ 4:33 PM
Study NCT ID:
NCT05167305
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2021-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1316}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-31', 'studyFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of in-hospital mortality rate of patients of liver disease admitted in April-May 2021 and April-May 2019.', 'timeFrame': 'Until discharge or death'}], 'secondaryOutcomes': [{'measure': 'Comparison of 30 days readmission rate of patients of liver disease.', 'timeFrame': 'Day 30'}, {'measure': 'Comparison of 31 to 90 days readmission rate of patients of liver disease.', 'timeFrame': 'Day 31-90'}, {'measure': 'Comparison of liver transplantation rates in the two time periods i.e., April-May 2021 and April-May 2019.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'Hospital record of the patients of liver disease admitted from April-May 2021 and April-May 2019 will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and the subsequent 30 d and 90 day readmission rate.\n\nMonitoring and assessment: Hospital records of all patients of liver disease needing admission during the April-May 2019 and 2021, but without active COVID-19 infection, will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and 30 d and 90 d readmission rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of liver disease without COVID-19 infection admitted in the time period April- May 2021 and April-May 2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of liver disease requiring hospital admission\n\nExclusion Criteria:\n\n1. Active COVID-19 infection at time of admission or acquiring during hospital stay.'}, 'identificationModule': {'nctId': 'NCT05167305', 'briefTitle': 'The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease-A Record Based Cross-Sectional Study.', 'orgStudyIdInfo': {'id': 'ILBS-COVID-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'liver disease without COVID-19 infection-April-May 2019', 'interventionNames': ['Other: This is an observational study']}, {'label': 'liver disease without COVID-19 infection -April- May 2021', 'interventionNames': ['Other: This is an observational study']}], 'interventions': [{'name': 'This is an observational study', 'type': 'OTHER', 'description': 'This is an observational study', 'armGroupLabels': ['liver disease without COVID-19 infection -April- May 2021', 'liver disease without COVID-19 infection-April-May 2019']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of Liver & Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}