Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT05601258
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2022-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lipase Levels and Coronavirus Disease 2019
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000375', 'term': 'Aging'}, {'id': 'D012723', 'term': 'Sex'}, {'id': 'D006760', 'term': 'Hospitalization'}], 'ancestors': [{'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of lipase enzyme elevation will be compared', 'timeFrame': 'From 31th March 2020 until 9th July 2021'}, {'measure': 'The mortaliy rate will be compared', 'timeFrame': 'From 31th March 2020 until 9th July 2021'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatitis', 'Lipase Increased']}, 'descriptionModule': {'briefSummary': 'Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common.\n\nIn this study, it was aimed retrospective analysis of clinical and laboratory data of patients who developed pancreatic injury and acute pancreatitis in the course of COVID 19 disease.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eighteen years of age or older, whose lipase level is measured in the course of COVID 19, will be included in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with lipase levels measured during COVID-19\n\nExclusion Criteria:\n\nPatients with age \\<18 years Patients with pregnancy Patients whose lipase levels were not measured in the course of COVID-19 Patients with known solid organ malignacy Patients with known hematologic malignacy'}, 'identificationModule': {'nctId': 'NCT05601258', 'briefTitle': 'Lipase Levels and Coronavirus Disease 2019', 'organization': {'class': 'OTHER', 'fullName': 'Uşak University'}, 'officialTitle': 'Association Between Pancreatic Lipase Levels and Coronavirus Disease 2019', 'orgStudyIdInfo': {'id': 'UsakUCevdet3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with higher lipase level', 'description': 'patients with higher lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection', 'interventionNames': ['Other: Age, gender, hospitalization and mortality rates will be compared']}, {'label': 'Control', 'description': 'patients with normal lipase levels in the course of SARS-CoV-2 infection', 'interventionNames': ['Other: Age, gender, hospitalization and mortality rates will be compared']}], 'interventions': [{'name': 'Age, gender, hospitalization and mortality rates will be compared', 'type': 'OTHER', 'description': 'Age, gender, hospitalization and mortality rates will be compared', 'armGroupLabels': ['Control', 'patients with higher lipase level']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64200', 'city': 'Uşak', 'country': 'Turkey (Türkiye)', 'facility': 'Cevdet Duran', 'geoPoint': {'lat': 38.67351, 'lon': 29.4058}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uşak University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cevdet Duran', 'investigatorFullName': 'Cevdet Duran', 'investigatorAffiliation': 'Uşak University'}}}}