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Clinical Trials/NCT04387968
NCT04387968CompletedNot Applicable

Epidemiological Study of the Covid-19 Presto Test Among Agents of the Local Authorities of CCTVL, Region Centre Val de Loire and Orleans Métropole. Correlation of IgM Level According to Contact With the Public

Raphael Serreau2 sites in 1 country3,228 target enrollmentStarted: August 24, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
3,228
Locations
2
Primary Endpoint
Study the prevalence of Covid-19 infection, coronavirus (SARS coronavirus-2) in territorial agents in the 3 structures : CCTVL, Loire Valley Region Centre, Orleans Metropolitan city

Study Overview

Brief Summary

The "COVIDOR" epidemiological study. Our study would be the first at the community level in Orleans Métropole, aiming to determine the link between a positive IgM level on the serological test and a healthy carrier of covid-19 in agents in contact with the public. It would provide epidemiological surveillance of anti-covid-19 immunity in the community

Detailed Description

The metropolitan area of Orléans Métropole has 6,700 agents divided into 250 different trades and consequently multiple exposures and risks.

The global covid-19 pandemic has affected France and the Loiret, the sarscov-2 coronavirus, has infected several thousand people. On May 7, 2020, there were 75 deaths at the CHRO hospital in Orleans, excluding EHPAD. The contamination rate of the population of the Loiret department has been estimated at 5.6% of the population by Public Health France. This rate is very low and does not allow the use of serological screening tests because of too many false positives or false negatives, there should be a prevalence of the disease greater than 60%. The French health authorities do not recommend the use of a screening test at the present time in view of the uncertainties of the results of this test. The Loiret Management Center, the Department and Orléans Métropole have decided to offer a covid-19 serological screening test, the covid-19 presto test, to voluntary territorial agents regardless of their return to work following the national "deconfinement "on May 11, 2020 This can only be done through an epidemiological surveillance study validated as part of a research protocol.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •All the agents of the 3 local authorities (Loire Valley Region, CCTVL and Orléans Métropole) being voluntary to be tested for the COVID-PRESTO® test COVID-19 IgG / IgM rapid test (whole blood / serum / plasma) - Cassette
  • •Volunteer to get tested

Exclusion Criteria

  • •Opposition to the participation of the study
  • •Covid-19 disease

Outcomes

Primary Outcomes

Study the prevalence of Covid-19 infection, coronavirus (SARS coronavirus-2) in territorial agents in the 3 structures : CCTVL, Loire Valley Region Centre, Orleans Metropolitan city

Time Frame: 15 minutes

Covid-19 attack rate by measuring the frequency of anti-covid-19 IgM in each of the territorial structures

Secondary Outcomes

  • Determine if there is a relationship between the profession carried out by the agents of the territorial community of Orleans metropolitan city, the Loire Valley Region, the CCTVL and contamination by covid-19(6 months)

Investigators

Sponsor
Raphael Serreau
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Raphael Serreau

Dr Raphaël SERREAU (PH)

Orléans Métropole Service de Médecine Préventive

Study Sites (2)

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