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

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

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

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 3228

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45000
    • Unité de Recherche PARADICT-O - Orléans
  • Orléans, France, 45000
    • Unité de Recherche PARADICT-O - Service de Médecine - Orléans Métropole

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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 Names: Covid-19 viro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Raphael Serreau
• Collaborators: Assistance Publique - Hôpitaux de Paris; University Hospital, Paris; François Rabelais University
• Investigators: Principal Investigator: Dr Raphael SERREAU, MD, PhD, Orleans Metropole

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): October 4, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: covid-19; serology; public health; depistage; voluntary agents
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 2020-A01414-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No