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CoVERED: COVID-19 Seroprevalence in Pregnant Women and Blood Donors

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04893057
Collaborator
(none)
800
Enrollment
15.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    SARS-CoV-2 sERoprévalences Dans la Population Des Femmes Enceintes et Donneurs de Sang
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Pregnant women

    Women admitted to hospital for a live birth.
    Blood donors

    Subjects qualified for whole blood donation

    Outcome Measures

    Primary Outcome Measures

    1. Anti-SARS-CoV-2 spike protein total IgG [at inclusion]

      Total IgG directed against anti-SARS-CoV-2 spike protein as measured by ELISA assay

    Secondary Outcome Measures

    1. Anti-SARS-CoV-2 nucleocapsid protein total IgG [at inclusion]

      Total IgG directed against anti-SARS-CoV-2 nucleocapsid protein as measured by ELISA assay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Pregnant women

    • Adult female

    • Admitted to hospital for live birth

    • Informed consent

    • Affiliated to the French social security health insurance scheme

    • Blood donors

    • Adult male or female

    • Qualified for whole blood donation (up to 70 years old in France)

    • Informed consent

    • Affiliated to the French social security health insurance scheme

    Exclusion Criteria:

    • Legal incapacity or limited legal capacity

    • Subject without health insurance coverage

    • Exclusion period of another study or exclusion period of the French national healthy volunteer registry

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    • Principal Investigator: Maxime Desmarets, MD, PhD, CHU Besançon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT04893057
    Other Study ID Numbers:
    • 2021/601
    First Posted:
    May 19, 2021
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Jul 14, 2022