COVID-19 Seroprevalence in Pregnant Women and Blood Donors | NCT04893057

Studies
COVID-19 Seroprevalence in Pregnant Women and Blood Donors

NCT04893057

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Oct 4, 2024Actual

Enrollment

797Actual

Phase

Not provided

Conditions

COVID-19 Respiratory Infection

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2022Actual

Primary Completion Date

Jan 4, 2023Actual

Completion Date

Jan 4, 2023Actual

First Submitted Date

May 11, 2021

First Submission Date that Met QC Criteria

May 11, 2021

First Posted Date

May 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2024

Last Update Posted Date

Oct 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

797Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women		Women admitted to hospital for a live birth.
Blood donors		Subjects qualified for whole blood donation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Adult pregnant women and adult blood donors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maxime Desmarets, MD, PhD	CHU Besançon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de besançon		Besançon			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided