Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT04365634
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2020-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-center Retrospective Study to Find Prediction Factors Related to Mortality of COVID-19 Patients.
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-25', 'studyFirstSubmitDate': '2020-04-25', 'studyFirstSubmitQcDate': '2020-04-25', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Find the prediction factors associated with hospitalized death of patients with COVID-19 by univariate and multivariate analysis', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Demographics and clinical characteristics', 'timeFrame': '28 days'}, {'measure': 'Laboratory parameters and radiography image features', 'timeFrame': '28 days'}, {'measure': 'Treatment, complications and clinical outcomes', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '33776910', 'type': 'DERIVED', 'citation': 'Han M, Ma K, Wang X, Yan W, Wang H, You J, Wang Q, Chen H, Guo W, Chen T, Ning Q, Luo X. Immunological Characteristics in Type 2 Diabetes Mellitus Among COVID-19 Patients. Front Endocrinol (Lausanne). 2021 Mar 11;12:596518. doi: 10.3389/fendo.2021.596518. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'In the single-centered, retrospective study, 306 hospital patients (including 129 diabetes and 177 non-diabetes patients) confirmed with SARS-CoV-2 infection were enrolled in Tongji Hospital, Wuhan, China. Clinical characteristics including clinical manifestation, laboratory parameters, lung CT features and clinical outcomes were compared between diabetes and non-diabetes patients. The prediction factors were analyzed for mortality of COVID-19 by univariate and multivariate analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The patients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China were enrolled. Laboratory confirmed cases were identified with positive viral RNA by real-time RT-PCR detection by the local health authority or our hospital from specimen taken from throat or nasal swab.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China.\n\nExclusion Criteria:\n\nWith SARS-CoV-2 RNA detection negative results."}, 'identificationModule': {'nctId': 'NCT04365634', 'briefTitle': 'A Single-center Retrospective Study to Find Prediction Factors Related to Mortality of COVID-19 Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Single-center Retrospective Study to Find Prediction Factors Related to Mortality of COVID-19 Patients by Univariate and Multivariate Analysis.', 'orgStudyIdInfo': {'id': 'TJ20200202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes', 'description': 'Diabetes mellitus was diagnosed according to the standards of American Diabetes Association which were briefly described as FPG ≥ 7.0 mmol/L (Fasting is defined as no caloric intake for at least 8 h) or 2-h plasma glucose ≥ 11.1 mmol/L during Oral glucose tolerance test (OGTT), or with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose (RPG) ≥ 11.1 mmol/L. And in this group, we have 129 COVID-19 patients with diabetes.'}, {'label': 'Non-diabetes', 'description': "Patients who do not meet the American Diabetes Association's standard diagnosis of diabetes are defined as non-diabetes. And in this group, we have 177 COVID-19 patients without diabetes."}, {'label': 'Survivors', 'description': 'COVID-19 patients who survived on the 28th day in hospital belong to survivors group. In the survivors group, we included 201 patients with complete data.'}, {'label': 'Non-survivors', 'description': 'COVID-19 patients who did not survive on the 28th day in hospital belong to non-survivors group. In the non-survivors group, we included 54 patients with complete data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Meifang Han, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qin Ning', 'investigatorAffiliation': 'Tongji Hospital'}}}}