Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-10 @ 11:50 PM
Study NCT ID:
NCT03443102
Status:
UNKNOWN
Last Update Posted:
2018-02-26
First Post:
2018-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Assessment of Organ Functions Among Survivors of Severe Acute Respiratory Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral Blood Mononuclear Cells would be extracted from participators.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2018-02-04', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause disability', 'timeFrame': 'Evaluations would be finished within 90 days after enrollment.', 'description': 'Disabilities arising from physical injuries and/or mental stresses'}], 'secondaryOutcomes': [{'measure': 'Cardiopulmonary function', 'timeFrame': 'Evaluations would be finished within 90 days after enrollment.', 'description': 'The interrelationship between the workings of the heart and lung organs would be assessed by assessed by 6MWT (6-min walk test)'}, {'measure': 'Life Life quaities mental distress', 'timeFrame': 'Evaluations would be finished within 90 days after enrollment.', 'description': 'Quality of life would be assessed by the Medical Outcomes Study 36-item short form version 2 (SF-36)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS Virus', 'Long-Term Survivors']}, 'referencesModule': {'references': [{'pmid': '34819019', 'type': 'DERIVED', 'citation': 'Li J, Zheng Y, Zhao L, Yue Z, Pan F, Chen Y, Yu B, Chen Y, Zhao G, Zhou Y, Gao Z. Investigation of the impact of SARS-CoV infection on the immunologic status and lung function after 15 years. BMC Infect Dis. 2021 Nov 24;21(1):1183. doi: 10.1186/s12879-021-06881-3.'}]}, 'descriptionModule': {'briefSummary': 'SARS-CoV has caused severe epidemic respiratory disease in human populations. By July 2003, a total of 8,096 probable cases of SARS had been reported including 774 deaths in 27 countries, around one-third of which were health care workers (HCWs). Previous studies have been reported about long-term impacts of SARS infection, including lung function deficiency, steroid-induced osteonecrosis, reduced exercise capacity, and impairment in health-related quality of life (HRQoL). HCWs, especially nurses, have been reported to experience greater psychological distress, particularly increased levels of posttraumatic stress symptomatology (PTSS). But the very complex impacts of this fatal infection on HCWs have not been fully elucidated. It is thus important to follow these occupational patients to detect and manage multi-organ sequelae and functional impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003 will be enrolled.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003\n\nExclusion Criteria:\n\n* Refusal to continue the study"}, 'identificationModule': {'nctId': 'NCT03443102', 'briefTitle': 'Long-term Assessment of Organ Functions Among Survivors of Severe Acute Respiratory Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'The 15-year Impact of Severe Acute Respiratory Syndrome on Organ Functions, Exercise Capacity, and Quality of Life in Survivors.', 'orgStudyIdInfo': {'id': '2018PHB010-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS survivors', 'description': "First-line HCWs infected during the SRAS-CoV pandemic in Peking University People's Hospital, China. Diagnose was further confirmed by SARS-CoV seropositive results."}, {'label': 'Controls', 'description': '1. Coworkers of the infected HCWs, who also exposed to SARS patients or specimens. Infection was further excluded by SARS-CoV seronegative results.\n2. Healthy controls matched for age, sex and disease condition, but without exposures to SARS virus.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yali Zheng, Dr', 'role': 'CONTACT', 'email': 'drylzheng@gmail.com', 'phone': '15011451515', 'phoneExt': '86'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yali Zheng, Dr', 'role': 'CONTACT', 'email': 'yali_zheng@126.com', 'phone': '+8615011451515'}, {'name': 'Jia Li, Dr', 'role': 'CONTACT', 'email': 'lj10120@sina.com', 'phone': '+8613661310120'}], 'overallOfficials': [{'name': 'Baoguo Jiang, Dr', 'role': 'STUDY_CHAIR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Respiartory and Critical Care Medicine', 'investigatorFullName': 'Zhancheng Gao', 'investigatorAffiliation': "Peking University People's Hospital"}}}}