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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anti-SARS-CoV2 Serology
Sponsored by
Université de Reims Champagne-Ardenne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Covid19 focused on measuring COVID-19, SARS-CoV2 antibodies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Université de Reims Champagne-Ardenne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Population

Arm Description

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

Outcomes

Primary Outcome Measures

Prevalence of IgG and IgM anti-SARS CoV2 antibodies
Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2021
Last Updated
March 24, 2021
Sponsor
Université de Reims Champagne-Ardenne
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1. Study Identification

Unique Protocol Identification Number
NCT04816084
Brief Title
SERUR: COVID-19 Serological Survey of Staff From the University Reims-Champagne Ardennes
Acronym
SERUR
Official Title
SERUR : Etude sérologique COVID-19 (Anti-SARS CoV 2) du Personnel de l'Université de Reims Champagne-Ardenne
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Reims Champagne-Ardenne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, SARS-CoV2 antibodies

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
389 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Population
Arm Type
Experimental
Arm Description
Voluntary people over 18 from the staff of the University of Reims Champagne Ardenne
Intervention Type
Diagnostic Test
Intervention Name(s)
Anti-SARS-CoV2 Serology
Other Intervention Name(s)
other : questionnaire
Intervention Description
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
Primary Outcome Measure Information:
Title
Prevalence of IgG and IgM anti-SARS CoV2 antibodies
Description
Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0.
Time Frame
Inclusion time was ½ day, time for blood sampling

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine GIUSTI, MCU-PH
Organizational Affiliation
Université de Reims CHampahne-Ardenne - CHU de Reims
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Reims Champagne-Ardenne
City
Reims
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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