Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-27 @ 12:12 PM
Study NCT ID:
NCT06235866
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-08
First Post:
2023-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Identification of Long-term Complications
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-10-08', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung function', 'timeFrame': '1 year', 'description': 'Pulmonary function indicators improved gradually'}, {'measure': 'Imaging of the lung', 'timeFrame': '1 year', 'description': 'The residual lesions in the lung were gradually absorbed'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 Pneumonia', 'Long-term complications', 'Lung function'], 'conditions': ['Severe COVID-19']}, 'descriptionModule': {'briefSummary': 'The investigators retrospectively analyze the clinical characteristics of severe COVID-19 in our hospital, and then establish a prediction model for long-term complications in patients with severe COVID-19, and strengthen follow-up to improve the prognosis of patients.', 'detailedDescription': 'At present, there is a lack of prediction models for the long-term complications of severe COVID-19. Therefore, the investigators used the hospital big data platform to retrospectively analyze the clinical characteristics of severe COVID-19 in our hospital, and conducted cohort follow-up of the changes in lung function including FEV1, FVC，FEV1% and DLCO, etc and and high-resolution CT of patients after discharge. COX model and other statistical methods were used to establish a prediction model for long-term complications of severe COVID-19, and early identification and intervention, strengthen follow-up, and improve the prognosis of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with severe COVID-19 in our hospital from December 8, 2022 to January 31, 2023 were enrolled', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patient met the diagnostic criteria for severe COVID-19\n\nExclusion Criteria:\n\n* Pregnant women Patients who died of COVID-19 Patients younger than 18 years of age without pulmonary CT'}, 'identificationModule': {'nctId': 'NCT06235866', 'briefTitle': 'Risk Identification of Long-term Complications', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Central Hospital'}, 'officialTitle': 'Risk Identification of Long-term Complications in the Recover Patients With Severe COVID-19', 'orgStudyIdInfo': {'id': '20230922'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Follow-up cohort of patients with severe COVID-19', 'description': 'The scores of various scales, pulmonary function and imaging changes of patients with severe COVID-19 were collected at 3 months, 6 months and 12 months after rehabilitation and discharge.', 'interventionNames': ['Other: Pulmonary rehabilitation']}], 'interventions': [{'name': 'Pulmonary rehabilitation', 'type': 'OTHER', 'description': 'According to the pulmonary rehabilitation guidelines, patients with severe COVID-19 were given regular rehabilitation treatment, including breathing exercises and physical rehabilitation exercises.', 'armGroupLabels': ['Follow-up cohort of patients with severe COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'country': 'China', 'facility': 'Follow-up of patients with severe COVID-19', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The project confidentiality agreement was observed, but the IPD could be made public after the study was completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}