NCT04816084

Brief Summary

This study was designed to determine, in a screening situation within the framework of university preventive medicine, the prevalence of positive anti-SARS-Cov 2 serology among the staff of the University of Reims Champagne-Ardenne. The serological tests chosen will allow systematic detection of anti-SARS-CoV-2 IgM and anti-SARS-Cov-2 IgG to assess the moment of potential contamination prior to resumption of occupational activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
389

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable covid19

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

26 days

First QC Date

March 19, 2021

Last Update Submit

March 24, 2021

Conditions

Keywords

COVID-19SARS-CoV2 antibodies

Outcome Measures

Primary Outcomes (1)

  • Prevalence of IgG and IgM anti-SARS CoV2 antibodies

    Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0.

    Inclusion time was ½ day, time for blood sampling

Study Arms (1)

Population

EXPERIMENTAL

Voluntary people over 18 from the staff of the University of Reims Champagne Ardenne

Diagnostic Test: Anti-SARS-CoV2 Serology

Interventions

Diagnostic Test: Anti-SARS-CoV2 Serology A blood sample is collected by venipuncture at Day 0. The anti-SARS-CoV2 serological status is measured by with fully automated MAGLUMI 2019-nCoV IgG and IgM chemiluminescence immunoassays (EUROBIO®) Other: Questionnaire Data concerning personal exposure factors are collected in a questionnaire: * Socio-demographic factors: sex, age, * known risk-factor for Covid-19 * Professional factors: Employment (type, work time, location), protective measures put in place to reduce the risk of contamination * Non-professional factors: Contact with infected individuals, carrying of protective equipment and compliance with barrier measures, transport and accomodation modalities during holidays

Also known as: other : questionnaire
Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major volunteers from the Staff of the University of Reims Champagne-Ardenne (\>18 years old)

You may not qualify if:

  • persons who do not desire to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Reims Champagne-Ardenne

Reims, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Delphine GIUSTI, MCU-PH

    Université de Reims CHampahne-Ardenne - CHU de Reims

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 25, 2021

Study Start

November 5, 2020

Primary Completion

December 1, 2020

Study Completion

March 15, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations