Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT04893057
Status:
COMPLETED
Last Update Posted:
2024-10-04
First Post:
2021-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Seroprevalence in Pregnant Women and Blood Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 797}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-SARS-CoV-2 spike protein total IgG', 'timeFrame': 'at inclusion', 'description': 'Total IgG directed against anti-SARS-CoV-2 spike protein as measured by ELISA assay'}], 'secondaryOutcomes': [{'measure': 'Anti-SARS-CoV-2 nucleocapsid protein total IgG', 'timeFrame': 'at inclusion', 'description': 'Total IgG directed against anti-SARS-CoV-2 nucleocapsid protein as measured by ELISA assay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Respiratory Infection']}, 'descriptionModule': {'briefSummary': 'The study aims to measure the SARS-CoV-2 seroprevalence (ie. the proportion of people with antibodies against the virus) in pregnant women and blood donors in an administrative area of France, and to determine whether these measures are representative of the general population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult pregnant women and adult blood donors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women\n\n * Adult female\n * Admitted to hospital for live birth\n * Informed consent\n * Affiliated to the French social security health insurance scheme\n* Blood donors\n\n * Adult male or female\n * Qualified for whole blood donation (up to 70 years old in France)\n * Informed consent\n * Affiliated to the French social security health insurance scheme\n\nExclusion Criteria:\n\n* Legal incapacity or limited legal capacity\n* Subject without health insurance coverage\n* Exclusion period of another study or exclusion period of the French national healthy volunteer registry'}, 'identificationModule': {'nctId': 'NCT04893057', 'acronym': 'CoVERED', 'briefTitle': 'COVID-19 Seroprevalence in Pregnant Women and Blood Donors', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'SARS-CoV-2 sERoprévalences Dans la Population Des Femmes Enceintes et Donneurs de Sang', 'orgStudyIdInfo': {'id': '2021/601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women', 'description': 'Women admitted to hospital for a live birth.'}, {'label': 'Blood donors', 'description': 'Subjects qualified for whole blood donation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'country': 'France', 'facility': 'CHU de besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Maxime Desmarets, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}