SERUR: COVID-19 Serological Survey of Staff From the University Reims-Champagne Ardennes

NCT ID: NCT04816084

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 389 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-05
• Study Completion Date: 2021-03-15

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.

Detailed Description

Objective:

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.

Type of study:

This is a prevalence study, a single-center cross-sectional study published on the human person.

Population:

Inclusion criteria: On a voluntary basis, the staff of the University of Reims Champagne Ardenne will be offered a serological blood test (1 dry tube of 7ml). The use of the collected data for research purposes will be explained to each requester, with signature of an informed consent. Only people over 18 will be included.

Non-inclusion criteria: Staff of the University of Reims Champagne Ardenne who have not requested to be tested. Duration of participation of subjects: 1/2 day time

Judgment criterion (s):

Main endpoint (in connection with the main objective): Prevalence of positive SARS-CoV-2 serology at the University of Reims Champagne-Ardenne.

Clinical investigation plan:

• Phase 1: Communication strategy An email will be sent to all the staff of the University of Reims Champagne Ardenne to offer them anti-SARS-Cov-2 serological tests, as part of a health research protocol. Before sampling, a questionnaire will be completed by the applicant.
• Phase 2: Analysis of the samples
• Phase 3: Transmission of results to Pr Frédéric Deschamps, head of SUMMPS at the University of Reims Champagne Ardenne

Conditions

Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Population

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

Group Type: EXPERIMENTAL

Anti-SARS-CoV2 Serology

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Anti-SARS-CoV2 Serology

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

other : questionnaire

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• persons who do not desire to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Reims Champagne-Ardenne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Delphine GIUSTI, MCU-PH

Role: PRINCIPAL_INVESTIGATOR

Université de Reims CHampahne-Ardenne - CHU de Reims

Locations

Université de Reims Champagne-Ardenne

Reims, , France

Countries

France

Other Identifiers

2020-004-SERUR

Identifier Type: -

Identifier Source: org_study_id