Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-03-04 @ 7:44 PM
Study NCT ID:
NCT05373459
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2022-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Third COVID-19 Booster Among Health Care Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719227', 'term': 'COVID-19 vaccine booster shot'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3167}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2022-05-12', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 Infection', 'timeFrame': 'During 1 February - 31 March 2022', 'description': 'Number of participants with COVID-19 infected'}, {'measure': 'Number of days return to work after COVID-19 infection', 'timeFrame': 'During 1 February - 31 March 2022', 'description': 'Number of days return to work after COVID-19 infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Vaccines']}, 'descriptionModule': {'briefSummary': 'A new wave of COVID-19 infections, mainly caused by the Omicron/ Delta variant, has been sweeping the globe since the start of 2022. In response, the administration of a third dose of COVID-19 vaccine was considered to address potential waning immunity over time and reduced effectiveness against the Omicron/ Delta variant. The pandemic also resulted in many infections among health care workers (HCWs) and their households. In this study, a retrospective analysis would perform on risk of COVID-19 infection and their outcome in relation to their COVID-19 vaccination history by using the data repository from one of the Hong Kong private hospitals.\n\nHCWs were required to submit a standardized online self-declaration form for report of 1) demographic of the HCWs, 2) symptoms related history and 3) COVID-19 exposure history once they were COVID-19 confirmed by rapid antigen test against COVID-19 and/or polymerase chain reaction (PCR) test for COVID-19. Subsequent follow up such as contact tracing, COVID-19 PCR testing results of these HCWs and status of return to work were captured by the infection control team in a systematic manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All full time staff members of the private hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All full time staff members of the private hospital\n\nExclusion Criteria:\n\n* History of COVID-19 before 2022'}, 'identificationModule': {'nctId': 'NCT05373459', 'briefTitle': 'Effect of a Third COVID-19 Booster Among Health Care Workers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hong Kong Sanatorium & Hospital'}, 'officialTitle': 'Effect of a Third COVID-19 Booster on COVID-19 Infection Rate and Return to Works During Fifth Wave COVID-19 Among Health Care Workers', 'orgStudyIdInfo': {'id': 'Third COVID-19 booster'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health care workers without third COVID-19 booster', 'description': 'Health care workers received less than 3 doses of COVID-19 vaccine'}, {'label': 'HCWs with third COVID-19 booster', 'description': 'Health care workers received at least 3 doses of COVID-19 vaccine', 'interventionNames': ['Biological: Third COVID-19 booster']}], 'interventions': [{'name': 'Third COVID-19 booster', 'type': 'BIOLOGICAL', 'description': 'Third COVID-19 booster', 'armGroupLabels': ['HCWs with third COVID-19 booster']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Hong Kong Sanatorium & Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Jonpaul Sze Tsing Zee, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hong Kong Sanatorium & Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Sanatorium & Hospital', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Infectious Disease', 'investigatorFullName': 'Dr. Jonpaul ST Zee', 'investigatorAffiliation': 'Hong Kong Sanatorium & Hospital'}}}}