Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT05387304
Status:
RECRUITING
Last Update Posted:
2022-05-24
First Post:
2022-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai
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': 'ESTIMATED', 'count': 250000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2032-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long-term outcomes，changes of clinical characteristic and social psychology', 'timeFrame': '10 years', 'description': 'the 3rd，6th，9th month，average one year discharge from hospital'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is to clarify the distribution characteristics, host and clinical characteristics, disease outcome and risk factors, changes of multiple organs such as cardiopulmonary function and changes in social and psychological indicators during long-term follow-up of omicron variant asymptomatic infections and diagnosed patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'asymptomatic infections and diagnosed patients with COVID-19 in fangcang shelter hospitals in Shanghai', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SARS-Cov-2-RNA positive\n* informed consent signed\n\nExclusion Criteria:\n\n* informed consent rejected'}, 'identificationModule': {'nctId': 'NCT05387304', 'briefTitle': 'A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai', 'orgStudyIdInfo': {'id': 'SCAM2022-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 infections', 'description': 'SARS-Cov-2 RNA postive'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Chen, Ph D', 'role': 'CONTACT', 'email': 'cy11530@rjh.com.cn', 'phone': '+8613917403314'}, {'name': 'Guang Ning, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Erzhen Chen, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ying Chen, Ph D', 'role': 'CONTACT', 'email': 'cy11530@rjh.com.cn', 'phone': '+8613917403314'}], 'overallOfficials': [{'name': 'Guang Ning, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Erzhen Chen, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data are not publicity available due to privacy and ethical restrictions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}