Clinical trial NCT04387968: Epidemiological Study of the Covid-19 Presto Test - The "COVIDOR" Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Keywords: covid-19
serology
depistage
public health
voluntary agents
Lead sponsor: Orléans Métropole Service de Médecine Préventive
Sponsor class: OTHER
Collaborators: name: François Rabelais University
name: Assistance Publique - Hôpitaux de Paris
name: University Hospital, Paris
First posted: 2020-05-14
Enrollment: 3228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Blood sample to be taken after self-bite. A consent form is given to the officer.

A drop of blood is deposited on a coverslip, 2 drops of reagents allow migration to the gel.

Reading in 15 minutes

1. strip: negative result
2. bands: positive result

An authorized person, subject to medical confidentiality, reports the result in the medical file and informs the agent of the result.

He is given a paper document signed by the SMP with the procedure to follow.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 15 minutes
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Orléans
country: France
facility: Unité de Recherche PARADICT-O - Orléans
city: Orléans
country: France
facility: Unité de Recherche PARADICT-O - Service de Médecine - Orléans Métropole
Study officials:
affiliation: Orleans Metropole
name: Dr Raphael SERREAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: