COVID-19 Seroprevalence in Pregnant Women and Blood Donors (CoVERED)

July 12, 2022 updated by: Centre Hospitalier Universitaire de Besancon

SARS-CoV-2 sERoprévalences Dans la Population Des Femmes Enceintes et Donneurs de Sang

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult pregnant women and adult blood donors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pregnant women
Women admitted to hospital for a live birth.
Blood donors
Subjects qualified for whole blood donation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-SARS-CoV-2 spike protein total IgG
Time Frame: at inclusion
Total IgG directed against anti-SARS-CoV-2 spike protein as measured by ELISA assay
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-SARS-CoV-2 nucleocapsid protein total IgG
Time Frame: at inclusion
Total IgG directed against anti-SARS-CoV-2 nucleocapsid protein as measured by ELISA assay
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Maxime Desmarets, MD, PhD, Chu Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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