Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT04591704
Status:
UNKNOWN
Last Update Posted:
2021-05-04
First Post:
2020-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Diabetes Mellitus on the Prognosis of Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006760', 'term': 'Hospitalization'}, {'id': 'D009026', 'term': 'Mortality'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D014798', 'term': 'Vital Statistics'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-01', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Hospitalisation', 'timeFrame': '1 year', 'description': 'The time between admission to hospital and discharge'}, {'measure': 'The need for ICU', 'timeFrame': '1 year', 'description': 'The admission of hospitalized patients to the intensive care unit.'}, {'measure': 'Mortality', 'timeFrame': '1 year', 'description': 'Mortality rates of patients'}, {'measure': 'Lung involvement', 'timeFrame': '1 year', 'description': 'The presence of lung involvement on thorax CT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.\n\nThe patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.", 'detailedDescription': 'All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.\n\nThe patients will be divided into two groups, as diabetics and non-diabetics. The diagnosis of diabetes mellitus will be extracted from the medical records and medical history of the patients hospitalised with COVID-19.\n\nThe COVID-19 patients medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients aged between 18-80 years, diagnosed and hospitalised for COVID-19 will be enrolled in to the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized for COVID-19\n\nExclusion Criteria:\n\n* Patients with known malignancy\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT04591704', 'acronym': 'COVID-19-DM2', 'briefTitle': 'The Effect of Diabetes Mellitus on the Prognosis of Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Uşak University'}, 'officialTitle': 'The Effect of Diabetes Mellitus on the Morbidity and Mortality Rates in Patients With COVID-19', 'orgStudyIdInfo': {'id': 'UU-DM003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic groups', 'description': 'COVID-19 patients with diabetes mellitus', 'interventionNames': ['Other: hospitalisation, necessity of ICU, mortality rate, lung involvement']}, {'label': 'Control groups', 'description': 'COVID-19 patients without diabetes mellitus', 'interventionNames': ['Other: hospitalisation, necessity of ICU, mortality rate, lung involvement']}], 'interventions': [{'name': 'hospitalisation, necessity of ICU, mortality rate, lung involvement', 'type': 'OTHER', 'description': 'hospitalisation, necessity of ICU, mortality rate, lung involvement', 'armGroupLabels': ['Control groups', 'Diabetic groups']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64200', 'city': 'Uşak', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Cevdet Duran', 'role': 'CONTACT', 'email': 'drcduran@gmail.com', 'phone': '02762212121'}], 'facility': 'Usak University Training and Research Hospital', 'geoPoint': {'lat': 38.67351, 'lon': 29.4058}}], 'centralContacts': [{'name': 'Cevdet Duran', 'role': 'CONTACT', 'email': 'drcduran@gmail.com', 'phone': '02762212121'}], 'overallOfficials': [{'name': 'Cevdet Duran', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uşak Üniversitesi Tıp fak'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uşak University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}