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

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ClinicalTrials.gov Identifier: NCT04387968
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : December 9, 2020
Sponsor:
Collaborators:
François Rabelais University
Assistance Publique - Hôpitaux de Paris
University Hospital, Paris
Information provided by (Responsible Party):
Raphael Serreau, Orléans Métropole Service de Médecine Préventive

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

Condition or disease Intervention/treatment
Coronavirus Infection Diagnostic Test: Covid-19 presto test

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : March 24, 2021
Estimated Study Completion Date : March 24, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
agents in contact with the public
patients working with children, policemen, desk office
Diagnostic Test: Covid-19 presto test
Use an auto-test in 15 minutes get the results about covid-19 anticorps
Other Name: Covid-19 viro

agents with no contact with the public
administrative workers
Diagnostic Test: Covid-19 presto test
Use an auto-test in 15 minutes get the results about covid-19 anticorps
Other Name: Covid-19 viro




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
blood drop to test IgM and IgG by an immunoserology rapid screening autotest and antigenic test


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387968


Contacts
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Contact: Dr Raphael SERREAU, MD, PhD 0616386878 raphael.serreauurc@gmail.com

Locations
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France
Unité de Recherche PARADICT-O - Service de Médecine - Orléans Métropole Recruiting
Orléans, France, 45000
Contact: Dr Raphaël O SERREAU, MD-PhD    0033238792437    raphael.serreau@orleans-metropole.fr   
Contact: Hanane GUERROUT, MD    0033238792437    hanane.guerrout@orleans-metropole.fr   
Principal Investigator: Raphaël SERREAU, MD, PhD         
Sub-Investigator: Xavier MICHEL, MD         
Sub-Investigator: Jean-Pierre DURAND, MD         
Sub-Investigator: Hanane GUERROUT, MD         
Unité de Recherche PARADICT-O - Service de Médecine - Orléans Métropole Recruiting
Orléans, France, 45000
Contact: Unité de Recherche PARADICT-O - Service de Médecine - O Métropole    0616386878    raphael.serreauurc@gmail.com   
Principal Investigator: Pr Raphael Serreau, MD, Phd         
Sponsors and Collaborators
Raphael Serreau
François Rabelais University
Assistance Publique - Hôpitaux de Paris
University Hospital, Paris
Investigators
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Principal Investigator: Dr Raphael SERREAU, MD, PhD Orleans Metropole
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Responsible Party: Raphael Serreau, Dr Raphaël SERREAU (PH), Orléans Métropole Service de Médecine Préventive
ClinicalTrials.gov Identifier: NCT04387968    
Other Study ID Numbers: 2020-A01414-35
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raphael Serreau, Orléans Métropole Service de Médecine Préventive:
covid-19
serology
depistage
public health
voluntary agents
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases