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临床试验/NCT04387968
NCT04387968已完成不适用

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

Raphael Serreau2 个研究点 分布在 1 个国家目标入组 3,228 人开始时间: 2020年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,228
试验地点
2
主要终点
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

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 15 minutes

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

次要结局

  • 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)

研究者

发起方
Raphael Serreau
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Raphael Serreau

Dr Raphaël SERREAU (PH)

Orléans Métropole Service de Médecine Préventive

研究点 (2)

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