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

NCT ID: NCT04387968

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-24

Study Completion Date

2021-10-04

Brief Summary

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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

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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.

Conditions

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Coronavirus Infection

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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agents in contact with the public

patients working with children, policemen, desk office

Covid-19 presto test

Intervention Type DIAGNOSTIC_TEST

Use an auto-test in 15 minutes get the results about covid-19 anticorps

agents with no contact with the public

administrative workers

Covid-19 presto test

Intervention Type DIAGNOSTIC_TEST

Use an auto-test in 15 minutes get the results about covid-19 anticorps

Interventions

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Covid-19 presto test

Use an auto-test in 15 minutes get the results about covid-19 anticorps

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Covid-19 viro

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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François Rabelais University

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

University Hospital, Paris

OTHER

Sponsor Role collaborator

Raphael Serreau

OTHER

Sponsor Role lead

Responsible Party

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Raphael Serreau

Dr Raphaël SERREAU (PH)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dr Raphael SERREAU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Orleans Metropole

Locations

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Unité de Recherche PARADICT-O - Orléans

Orléans, , France

Site Status

Unité de Recherche PARADICT-O - Service de Médecine - Orléans Métropole

Orléans, , France

Site Status

Countries

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France

References

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Hanane G, Amine Z, Roomila N, Prazuck T, Amirouche A, Olivier V, Benyamina A, Serreau R. COVID-19 seroprevalence among local authority workers from Orleans Metropole, the Community of Communes of the Terres du Val de Loire, the local public service management centre of the Loiret department and the Region Centre Val de Loire: a prospective epidemiological study. BMJ Open. 2023 May 22;13(5):e066504. doi: 10.1136/bmjopen-2022-066504.

Reference Type DERIVED
PMID: 37217267 (View on PubMed)

Other Identifiers

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2020-A01414-35

Identifier Type: -

Identifier Source: org_study_id

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