Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-30 @ 2:51 AM
Study NCT ID:
NCT05615792
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2022-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Cohort of COVID-19 Patients in Hubei Province
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '2 years', 'description': 'Numbers and dates of death in each group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-CoV-2', 'Risk Factors', 'Mortality'], 'conditions': ['2019 Novel Coronavirus Disease']}, 'referencesModule': {'references': [{'pmid': '38467760', 'type': 'DERIVED', 'citation': 'Li D, He W, Yu B, Wang DW, Ni L. NT-proBNP ratio is a potential predictor for COVID-19 outcomes in adult Chinese patients: a retrospective study. Sci Rep. 2024 Mar 11;14(1):5906. doi: 10.1038/s41598-024-56329-2.'}, {'pmid': '37566218', 'type': 'DERIVED', 'citation': 'Xu K, He W, Yu B, Zhong K, Zhou D, Wang DW. Beneficial Effects of Angiotensin II Receptor Blockers on Mortality in Patients with COVID-19: A Retrospective Study from 2019 to 2020 in China. Cardiovasc Drugs Ther. 2025 Feb;39(1):63-74. doi: 10.1007/s10557-023-07494-5. Epub 2023 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'This study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.', 'detailedDescription': "Hubei Province, as the forefront of the fight against epidemic, has the largest number of patients infected with SARS-CoV-2 and the highest quality medical data. However, so far, these data have not been fully analyzed, if these data can not be mined and used, it will be a great loss to the whole human race. By fully mining and analyzing these data, we can sum up a large number of experiences related to COVID-19, summarize various laws of this kind of disease, and provide clinical evidence based on large samples for the research of this disease, eventually contribute China's experience to the global fight against the epidemic.\n\nBased on the above background, this study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study is a hospital-based observational study initiated by Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology. Trained researchers are responsible for screening and joining the group. About 6,8000 COVID-19 patients in Hubei Province were expected to be included in this study. Patients enrolled in the group will undergo baseline survey and follow-up according to the program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18, regardless of gender;\n2. A history of epidemiology, including travel or residence in high-risk areas or other communities with case reports within 14 days before the onset of the disease, or have a history of contact with novel coronavirus infection (those who are positive for nucleic acid tests); or patients with fever or respiratory symptoms from the community with case reports; or aggregative onset;\n3. Corresponding clinical manifestations, including respiratory symptoms such as fever, with typical imaging features of COVID-19, normal or decreased white blood cell count and decreased lymphocyte count in the early stage of the disease;\n4. Clear etiological evidence, including real-time fluorescent RT-PCR detection of novel coronavirus nucleic acid positive, or viral gene sequencing, is highly homologous to novel coronavirus.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria cannot be enrolled in this study:\n\n1. Patients refused to participate in this study;\n2. According to the researchers, patients are unable to complete this study or comply with the requirements of this study (due to management or other reasons).'}, 'identificationModule': {'nctId': 'NCT05615792', 'acronym': 'OCCP-HP', 'briefTitle': 'Observational Cohort of COVID-19 Patients in Hubei Province', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Observational Cohort of The Effects of Clinical Indicators, Drug Use and Genotypes on The Clinical Prognosis of COVID-19 Patients in Hubei Province', 'orgStudyIdInfo': {'id': 'TJ-COVID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with coronavirus disease 2019 (COVID-19)', 'description': 'Patients diagnosed with COVID-19 in Hubei Province', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['patients with coronavirus disease 2019 (COVID-19)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dao Wen Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Dao Wen Wang', 'investigatorAffiliation': 'Tongji Hospital'}}}}