NCT04893057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
797

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

May 11, 2021

Last Update Submit

October 3, 2024

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (1)

  • Anti-SARS-CoV-2 spike protein total IgG

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

    at inclusion

Secondary Outcomes (1)

  • Anti-SARS-CoV-2 nucleocapsid protein total IgG

    at inclusion

Study Arms (2)

Pregnant women

Women admitted to hospital for a live birth.

Blood donors

Subjects qualified for whole blood donation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult pregnant women and adult blood donors

You may qualify if:

  • 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

You may not qualify if:

  • Legal incapacity or limited legal capacity
  • Subject without health insurance coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de besançon

Besançon, France

Location

Study Officials

  • Maxime Desmarets, MD, PhD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 19, 2021

Study Start

September 15, 2022

Primary Completion

January 4, 2023

Study Completion

January 4, 2023

Last Updated

October 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)