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

NCT04387968 | Completed

• 1 other identifier: 2020-A01414-35
• Study Type: observational
• Target: 3,228
• Locations: 1 country
• Sites: 2

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

Conditions

Coronavirus Infection

Keywords

covid-19; serology; depistage; public health; voluntary agents

Outcome Measures

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

  Covid-19 attack rate by measuring the frequency of anti-covid-19 IgM in each of the territorial structures

  15 minutes

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

  6 months

Study Arms (2)

agents in contact with the public

patients working with children, policemen, desk office

Diagnostic Test: Covid-19 presto test

agents with no contact with the public

administrative workers

Diagnostic Test: Covid-19 presto test

Interventions

Covid-19 presto test DIAGNOSTIC_TEST

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

Also known as: Covid-19 viro

agents in contact with the public; agents with no contact with the public

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Opposition to the participation of the study
• Covid-19 disease

Sponsors & Collaborators

• Raphael Serreau: lead
• François Rabelais University: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• University Hospital, Paris: collaborator

Study Sites (2)

Unité de Recherche PARADICT-O - Orléans

Orléans, 45000, France

Location

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

Orléans, 45000, France

Location

Related Publications (1)

• 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.

  PMID: 37217267 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood drop to test IgM and IgG by an immunoserology rapid screening autotest and antigenic test

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr Raphael SERREAU, MD, PhD

  Orleans Metropole

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Raphaël SERREAU (PH)

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 14, 2020
• Study Start: August 24, 2020
• Primary Completion: July 13, 2021
• Study Completion: October 4, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

FR (2)