Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-28 @ 10:51 AM
Study NCT ID:
NCT04371692
Status:
COMPLETED
Last Update Posted:
2021-04-23
First Post:
2020-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of COVID-19 Infection Among HCW in a French University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086742', 'term': 'COVID-19 Testing'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection', 'timeFrame': 'at 2 months'}], 'secondaryOutcomes': [{'measure': 'the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection', 'timeFrame': 'once week during 2 months'}, {'measure': 'Occupational exposures associated with the SARS-Cov2 infection', 'timeFrame': 'once week during 2 months'}, {'measure': 'Environmental exposures associated with the SARS-Cov2 infection', 'timeFrame': 'once week during 2 months'}, {'measure': 'immunologic status of health Care Worker', 'timeFrame': 'once week during 2 months'}, {'measure': 'inflammatory biomarkers status of Health Care Worker', 'timeFrame': 'once week during 2 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prevalence', 'Health Care Workers', 'occupational exposure', 'environmental exposure', 'serological testing', 'RT-PCR'], 'conditions': ['Sars-CoV2']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health Care workers with or without symptoms suggestive of a COVID-19 infection', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Health Care workers with or without symptoms suggestive of a COVID-19 infection\n\nExclusion Criteria:\n\n* HCW working off-site at the CHU de Lille\n* HCW on sick leave.\n* HCW outside the Lille University Hospital temporarily coming as reinforcements in the context of the epidemic.'}, 'identificationModule': {'nctId': 'NCT04371692', 'acronym': 'EXPOCOVIA', 'briefTitle': 'Prevalence of COVID-19 Infection Among HCW in a French University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Prevalence of SARS-Cov2 Infection Among HCW in Lille University Hospital', 'orgStudyIdInfo': {'id': '2020_35'}, 'secondaryIdInfos': [{'id': '2020-A00951-38', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'High-risk', 'description': 'staff working in a unit specifically for patients infected or suspected of being infected with SARS-Cov2', 'interventionNames': ['Other: self-administered questionnaire', 'Diagnostic Test: SARS-Cov2 testing']}, {'label': 'Medium- risk', 'description': 'staff working in a unit that can accommodate patients infected or suspected of being infected with SARS-Cov2, i.e., all care services that do not fall into the high-risk group.', 'interventionNames': ['Other: self-administered questionnaire', 'Diagnostic Test: SARS-Cov2 testing']}, {'label': 'Low-risk', 'description': 'off-patient staff', 'interventionNames': ['Other: self-administered questionnaire', 'Diagnostic Test: SARS-Cov2 testing']}], 'interventions': [{'name': 'self-administered questionnaire', 'type': 'OTHER', 'otherNames': ['a specifically designed self-administered questionnaire'], 'description': 'Every weeks during 2 months, clinical and occupational questionnaire are performed among a cohort of HCW exposed to covid occupational exposure', 'armGroupLabels': ['High-risk', 'Low-risk', 'Medium- risk']}, {'name': 'SARS-Cov2 testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Every weeks during 2 month, SARS-Cov2 RT-PCR, serological testing are performed among a cohort of HCW exposed to covid occupational exposure', 'armGroupLabels': ['High-risk', 'Low-risk', 'Medium- risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hop Claude Huriez Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Annie SOBASZEK, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Santé Roquette', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}