Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-31 @ 2:06 AM
Study NCT ID:
NCT04550403
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2020-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 757}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients', 'timeFrame': 'february 23 to march 31, 2020', 'description': 'to assess risk of intensive care unit admission and/or death among COVID-19 inpatients'}], 'secondaryOutcomes': [{'measure': 'prevalence of death among COVID-19 inpatients with and without diabetes', 'timeFrame': 'february 23 to march 31, 2020', 'description': 'to compare risk of death among inpatients in presence or absence of diabetes'}, {'measure': 'prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes', 'timeFrame': 'february 23 to march 31, 2020', 'description': 'to compare intensive care unit admission among inpatients in presence or absence of diabetes'}, {'measure': 'demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization', 'timeFrame': 'february 23 to march 31, 2020', 'description': 'to identify socio-demographic as predictors of severe prognosis (death or intensive care unit admission) during hospitalization'}, {'measure': 'laboratory parameters (glycated hemoglobin, glucose at admission, renal and liver function markers, blood count, inflammatory markers, hemostasis) and death and/or intensive care unit admission during hospitalization', 'timeFrame': 'february 23 to march 31, 2020', 'description': 'to identify laboratory variables as predictors of severe prognosis (death or intensive care unit admission) during hospitalization'}, {'measure': 'pharmacological therapies and death and/or intensive care unit admission during hospitalization', 'timeFrame': 'february 23 to march 31, 2020', 'description': 'to identify pharmacological therapies as predictors of severe prognosis (death or intensive care unit admission) during hospitalization'}, {'measure': 'number of days of hospitalization in patients with and without diabetes', 'timeFrame': 'february 23 to march 31, 2020', 'description': 'to compare total length of hospitalization in patients with or without diabetes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'Covid-19', 'inhospital mortality', 'intensive care unit'], 'conditions': ['Diabetes Mellitus', 'Covid19']}, 'referencesModule': {'references': [{'pmid': '32145185', 'type': 'BACKGROUND', 'citation': 'Memish ZA, Perlman S, Van Kerkhove MD, Zumla A. Middle East respiratory syndrome. Lancet. 2020 Mar 28;395(10229):1063-1077. doi: 10.1016/S0140-6736(19)33221-0. Epub 2020 Mar 4.'}, {'pmid': '18948167', 'type': 'BACKGROUND', 'citation': 'Bindom SM, Lazartigues E. The sweeter side of ACE2: physiological evidence for a role in diabetes. Mol Cell Endocrinol. 2009 Apr 29;302(2):193-202. doi: 10.1016/j.mce.2008.09.020. Epub 2008 Oct 1.'}, {'pmid': '19333547', 'type': 'BACKGROUND', 'citation': 'Yang JK, Lin SS, Ji XJ, Guo LM. Binding of SARS coronavirus to its receptor damages islets and causes acute diabetes. Acta Diabetol. 2010 Sep;47(3):193-9. doi: 10.1007/s00592-009-0109-4. Epub 2009 Mar 31.'}, {'pmid': '32294179', 'type': 'BACKGROUND', 'citation': 'Drucker DJ. Coronavirus Infections and Type 2 Diabetes-Shared Pathways with Therapeutic Implications. Endocr Rev. 2020 Jun 1;41(3):bnaa011. doi: 10.1210/endrev/bnaa011.'}, {'pmid': '32267833', 'type': 'BACKGROUND', 'citation': 'Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi: 10.18632/aging.103000. Epub 2020 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'Patients with diabetes have been listed as people at higher risk for severe illness from COVID-19. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This observational study aims to to evaluate the risk of disease severity and mortality in association with diabetes in COVID-19 inpatients and identify the clinical and biological features associated with worse outcomes.', 'detailedDescription': 'The epidemic of coronavirus disease-2019 (COVID-19), a disease caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) virus, rapidly spread worldwide and was declared a pandemic by the World Health Organization on 11 March 2020.\n\nIt is well known that people with diabetes have increased infection risk, especially for influenza and pneumonia. Moreover, diabetes was previously reported as a major risk factor for mortality in people infected with the H1N1 pandemic influenza and, more recently, with the Middle East respiratory syndrome-related coronavirus (MERS-CoV) . Epidemiological studies have quickly and consistently pointed out diabetes as one of the major comorbidities associated with COVID-19 and affecting its severity.\n\nThe prevalence of diabetes in patients with COVID-19 was first reported to range from 5% to 20%. Furthermore, the COVID-19-Associated Hospitalisation Surveillance Network (COVID-NET) reported a diabetes prevalence of 28.3% in hospitalised patients in the USA.\n\nMore importantly, all studies published so far have reported a two- to threefold higher prevalence of diabetes in patients in ICUs compared with those with less severe disease and an increased mortality in people with diabetes. A recent meta-analysis further demonstrated that diabetes was associated with a more than doubled risk for ICU admission and a more than tripled risk for death.\n\nHowever, precise data regarding diabetes characteristics in hospitalised people with COVID-19 are still lacking. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This study aims to identify the clinical and biological features and potential interactions of diabetic therapies associated with disease severity and mortality risk in people hospitalised for COVID-19. Hospital medical records of inpatients, hospitalized between February 23 to March 31 2020, at the Internal Medicine Unit dedicated to COVID-19 in the Academic Hospital of Parma, Italy will be analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with and without diabetes, hospitalized for COVID-19 between February 23 to March 31 2020, at the Internal Medicine Unit dedicated to COVID-19 in the Academic Hospital of Parma, Italy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admission with COVID-19 to the Internal Medicine Unit dedicated to COVID-19 (Macrounit 1), academic hospital in Parma (Italy) between February 23 to March 31 2020.\n\nExclusion Criteria:\n\n* during hospitalization inter or intra-hospital transfer of inpatients'}, 'identificationModule': {'nctId': 'NCT04550403', 'briefTitle': 'Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria di Parma'}, 'officialTitle': 'Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes', 'orgStudyIdInfo': {'id': '27557'}}, 'contactsLocationsModule': {'locations': [{'zip': '43126', 'city': 'Parma', 'country': 'Italy', 'facility': 'Endocrinology and metabolic diseases Unit', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Riccardo Bonadonna, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero-Universitaria di Parma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria di Parma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Endocrinology and metabolic diseases unit', 'investigatorFullName': 'Riccardo Bonadonna', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria di Parma'}}}}