Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT04362267
Status:
UNKNOWN
Last Update Posted:
2020-08-06
First Post:
2020-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longitudinal Study 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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing', 'timeFrame': 'at 14 weeks'}], 'secondaryOutcomes': [{'measure': 'the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing', 'timeFrame': 'once every 14 days for an average of 14 weeks'}, {'measure': 'Occupational exposures associated with the SARS-Cov2 infection', 'timeFrame': 'once every 14 days for an average of 14 weeks'}, {'measure': 'Environmental exposures associated with the SARS-Cov2 infection', 'timeFrame': 'once every 14 days for an average of 14 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Incidence', 'Health Care Workers', 'occupational exposure', 'environmental exposure', 'serological testing', 'RT-PCR'], 'conditions': ['Sars-CoV2']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the incidence o of SARS-cov2 infection among health care workers highly exposed to covid 19 during 10 weeks et to analyze the determinants of their occupational and environmental exposure. Every 14 days, we performed SARS-Cov2 RT- PCR, serological testing and clinical questionnaire among a cohort of 100 HCW with a high degree of exposure to covid19 infection. Information about occupational exposure as the workplace, the activity of care, the characteristics of patient infected are captured, as well as environmental or personal exposure.\n\nThe results will support the design of a new care organization and will define new ways of protection for patients (covid or not covid 19) and prevention for HCW.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health Care workers exposed to covid occupational exposure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Health Care workers with covid high exposure during the care activities\n\nExclusion Criteria:\n\n* Heath Care Worker with SARS-Cov2 infection ( RT-PCR +) or SARS-Cov2 immunity in serological testing\n* HCW off work\n* Subjects on leave'}, 'identificationModule': {'nctId': 'NCT04362267', 'acronym': 'PRECOVIA', 'briefTitle': 'Longitudinal Study of Covid-19 Infection Among HCW in a French University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Incidence of SARS-Cov2 Infection Among HCW in Lille University Hospital', 'orgStudyIdInfo': {'id': '2020_34'}, 'secondaryIdInfos': [{'id': '2020-A00950-39', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'self-administered questionnaire', 'type': 'OTHER', 'otherNames': ['a specifically designed self-administered questionnaire'], 'description': 'Every14 days, clinical and occupational questionnaire are performed among a cohort of HCW exposed to covid occupational exposure'}, {'name': 'SARS-Cov2 testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Every14 days, SARS-Cov2 RT-PCR, serological testing are performed among a cohort of HCW exposed to covid occupational exposure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '0320445962'}, {'name': 'Annie Sobaszek, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Claude Huriez, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Annie SOBASZEK, MD,PhD', 'role': 'CONTACT', 'email': 'annie.sobaszek@chru-lille.fr', 'phone': '03.20.44.43.66', 'phoneExt': '+33'}], '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'}}}}