Trials / Completed
CompletedNCT04816084
SERUR: COVID-19 Serological Survey of Staff From the University Reims-Champagne Ardennes
SERUR : Etude sérologique COVID-19 (Anti-SARS CoV 2) du Personnel de l'Université de Reims Champagne-Ardenne
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 389 (actual)
- Sponsor
- Université de Reims Champagne-Ardenne · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-11-05
- Primary completion
- 2020-12-01
- Completion
- 2021-03-15
- First posted
- 2021-03-25
- Last updated
- 2021-03-25
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04816084. Inclusion in this directory is not an endorsement.