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

SERUR : Etude sérologique COVID-19 (Anti-SARS CoV 2) du Personnel de l'Université de Reims Champagne-Ardenne

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Anti-SARS-CoV2 Serology

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

• Study Type: Interventional
• Enrollment (Actual): 389
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Reims, France
    • Université de Reims Champagne-Ardenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria (Non Inclusion):

• persons who do not desire to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Population; Voluntary people over 18 from the staff of the University of Reims Champagne Ardenne

Diagnostic test: 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; Other Names: other : questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Université de Reims Champagne-Ardenne
• Investigators: Principal Investigator: Delphine GIUSTI, MCU-PH, Université de Reims CHampahne-Ardenne - CHU de Reims

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2020
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): March 15, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (ACTUAL): March 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; SARS-CoV2 antibodies
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-004-SERUR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No