Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT04429594
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2020-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Incidence of SARS-CoV-2 Infection (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive serologies', 'timeFrame': '12 months', 'description': 'number of positive serologies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Infections']}, 'referencesModule': {'references': [{'pmid': '37606852', 'type': 'DERIVED', 'citation': 'Graca D, Brglez V, Allouche J, Zorzi K, Fernandez C, Teisseyre M, Cremoni M, Benzaken S, Pradier C, Seitz-Polski B. Both Humoral and Cellular Immune Responses to SARS-CoV-2 Are Essential to Prevent Infection: a Prospective Study in a Working Vaccinated Population from Southern France. J Clin Immunol. 2023 Nov;43(8):1724-1739. doi: 10.1007/s10875-023-01558-9. Epub 2023 Aug 22.'}, {'pmid': '37063916', 'type': 'DERIVED', 'citation': 'Buscot M, Cremoni M, Graca D, Brglez V, Courjon J, Allouche J, Teisseyre M, Boyer L, Barriere J, Chamorey E, Carles M, Seitz-Polski B. Breakthrough infections due to SARS-CoV-2 Delta variant: relation to humoral and cellular vaccine responses. Front Immunol. 2023 Mar 30;14:1145652. doi: 10.3389/fimmu.2023.1145652. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study.\n\nThe health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality.\n\nThe occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the study by partner institutions (Departmental Council 06), affiliated to a social security scheme,\n\nExclusion Criteria:\n\n* Subject protected by law under tutorship or guardianship, or who cannot participate in a clinical study under the terms of Article L. 1121-16 of the French Public Health Code'}, 'identificationModule': {'nctId': 'NCT04429594', 'acronym': 'CovImmune 2', 'briefTitle': 'Study of the Incidence of SARS-CoV-2 Infection (COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement', 'orgStudyIdInfo': {'id': '20-PP-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'volonteers', 'interventionNames': ['Other: blood sampling']}], 'interventions': [{'name': 'blood sampling', 'type': 'OTHER', 'description': 'blood sampling at J0, M6, M12, M24, M36, M48, M60', 'armGroupLabels': ['volonteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Barbara SEITZ- POLSKI', 'role': 'CONTACT', 'email': 'seitz-polski.b@chu-nice.fr', 'phone': '334.92.03.55.02'}, {'name': 'barbara SEITZ POLSKI', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'sonia BOYER SUAVET', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christian PRADIER', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Nice Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Barbara SEITZ, MCUPH', 'role': 'CONTACT', 'email': 'seitz-polski.b@chu-nice.fr', 'phone': '334 92 03 55 02'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}