Epidemiological Study of the Covid-19 Presto Test - The "COVIDOR" Study

Coronavirus Infection Clinical Trial

— COVIDOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387968
• Other study ID #: 2020-A01414-35
• Status: Completed
• Start date: August 24, 2020
• Est. completion date: October 4, 2021

Study information

• Verified date: October 2021
• Source: Orléans Métropole Service de Médecine Préventive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3228
• Est. completion date: October 4, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19

Intervention

Diagnostic Test:
• Covid-19 presto test
Use an auto-test in 15 minutes get the results about covid-19 anticorps

Locations

Country	Name	City	State
France	Unité de Recherche PARADICT-O - Orléans	Orléans
France	Unité de Recherche PARADICT-O - Service de Médecine - Orléans Métropole	Orléans

Sponsors (4)

Lead Sponsor	Collaborator
Raphael Serreau	Assistance Publique - Hôpitaux de Paris, François Rabelais University, University Hospital, Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Covid-19 attack rate by measuring the frequency of anti-covid-19 IgM in each of the territorial structures	15 minutes
Secondary	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	Search for a correlation of covid-19 immunity based on the officer's position, if he is in contact with the public.	6 months