Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT04342702
Status:
UNKNOWN
Last Update Posted:
2020-05-05
First Post:
2020-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on the Prospective Cohort Library of COVID-19 in Southeran
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-03', 'studyFirstSubmitDate': '2020-04-04', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '36-Item Short Form Survey Instrument (SF-36)', 'timeFrame': 'one month, three month, six month and one year after discharge, minimum score', 'description': 'sum score of SF 36 form in each time frame'}, {'measure': 'the value of FEV1 by lung function test', 'timeFrame': 'one month, three month, six month and one year after discharge'}, {'measure': 'the ratio of FEV1 to FVC by lung function test', 'timeFrame': 'one month, three month, six month and one year after discharge'}], 'secondaryOutcomes': [{'measure': 'the predicted value of FEV1 by lung function test', 'timeFrame': 'one month, three month, six month and one year after discharge'}, {'measure': 'the predicted ratio of FEV1 to FVC by lung function test', 'timeFrame': 'one month, three month, six month and one year after discharge'}, {'measure': 'Lymphocyte value', 'timeFrame': 'one month, three month, six month and one year after discharge', 'description': 'laboratory result'}, {'measure': 'Neutrophil value', 'timeFrame': 'one month, three month, six month and one year after discharge', 'description': 'laboratory result'}, {'measure': 'DDI value', 'timeFrame': 'one month, three month, six month and one year after discharge', 'description': 'laboratory result'}, {'measure': 'the proportion of applying ACEIs/ARBs medication', 'timeFrame': 'from the date of hospital admission to the day of hospital discharge', 'description': 'collect the number of applying ACEIs/ARBs medication and calculate the proportion'}, {'measure': 'number of clinical symptoms after hospital discharge', 'timeFrame': 'one month, three month, six month and one year after discharge', 'description': 'clinical symptoms'}, {'measure': 'number of cases returning to positive result in RT-PCR test', 'timeFrame': 'one month, three month, six month and one year after discharge'}, {'measure': 'Number of positive outcome of IgG for antibody of COVID-19', 'timeFrame': 'one month, three month, six month and one year after discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Follow-up', 'COVID-19', 'Infectious Diseases', 'Respiratory']}, 'descriptionModule': {'briefSummary': "This is a multi-centre population-based follow-up study for all 504 patients with laboratory-confirmed COVID-19. This study establishes a standardized and structured clinical database to provide complete and multidimensional clinical diagnosis and treatment data of novel coronavirus pneumonia, which also support future epidemiological, infectious disease study and patients' prognosis, by collecting clinical data and the related data of patients with novel coronavirus pneumonia in Southern Zhejiang province.", 'detailedDescription': 'The follow-up information will be collected in one-month, three-month, six-month and one-year after discharge. Information about symptoms, radiographic and laboratory findings, lung function, SF-36 QUESTIONNAIRE, antibody of COVID19，result of RT-PCR Test and suvival information will be collected through all time frames.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Among all 504 patients with laboratory-confirmed COVID-19, 190 patients were classified as the imported cohort, and 311 patients were classified into the secondary cohort, three patients were excluded. The patients' inclusion cutoff was March 15, 2020.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with laboratory-confirmed COVID-19 in Wenzhou\n\nExclusion Criteria:\n\n* Suspected cases of COVID-19'}, 'identificationModule': {'nctId': 'NCT04342702', 'briefTitle': 'A Study on the Prospective Cohort Library of COVID-19 in Southeran', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'A Study on the Prospective Cohort Library of Novel Coronavirus Pneumonia in Southeran', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2020-NCP-202'}}, 'contactsLocationsModule': {'locations': [{'zip': '325035', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University", 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': "Wenzhou Central Hospital And Sixth People's Hospital of Wenzhou Medical University", 'class': 'UNKNOWN'}, {'name': 'Yueqing Hospital of Wenzhou Medical University', 'class': 'UNKNOWN'}, {'name': 'Ruian Hospital of Wenzhou Medical University', 'class': 'UNKNOWN'}, {'name': 'Cangnan Hospital of Wenzhou Medical University', 'class': 'UNKNOWN'}, {'name': 'Pingyang Hospital of Wenzhou Medical University', 'class': 'UNKNOWN'}, {'name': "Yongjia People's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaokun Li', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}