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NCT Number: NCT04387968

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

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

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Key information

Conditions

Coronavirus Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Unité de Recherche PARADICT-O - Orléans, Orléans, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Covid-19 presto test

Diagnostic Test

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

Other names: Covid-19 viro

Primary outcomes

  1. 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

  1. 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

    Time frame: 6 months

    Search for a correlation of covid-19 immunity based on the officer's position, if he is in contact with the public.

Sponsors and collaborators

Lead sponsor

Raphael Serreau

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • François Rabelais University
  • University Hospital, Paris

Registry information

Official study 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

Acronym: COVIDOR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 14, 2020
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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