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临床试验/NCT04429724
NCT04429724已完成不适用

Health Professional Exposure Assessment to Covid-19

Tourcoing Hospital4 个研究点 分布在 1 个国家目标入组 2,129 人开始时间: 2020年7月6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
2,129
试验地点
4
主要终点
Number of contaminated personnel

研究概览

简要总结

Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community and in the hospital sector. Because of their central position in the management of patients infected with COVID-19, hospital staff may be considered at high risk of infection. The development of serological tests makes it possible to reliably document a contamination, symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical questioning of the symptoms, make it possible to determine the proportion of asymptomatic infections whose impact in the transmission of this disease appears to be major. The duration of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS remains uncertain. Documenting the evolution of antibody levels and their monitoring in a population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this disease and in assessing the risk of infection among healthcare workers.

详细描述

This is a multi-center, prospective, interventional, low-risk, low-constraint, biological collection study to assess the exposure of health care workers to COVID-19.

Three blood samples will be taken at day 1, month 3 and month 6. The blood samples will be stored in a serum biological collection. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.

In the event of the appearance of symptoms between samples, a self-questionnaire will be completed by the participating personnel as well as an invitation to screening by RT-PCR SARS Cov2 according to standard practices in force at the national level as well as an additional serological test.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Staff on duty in the health facility
  • Eligible to be drawn
  • Beneficiary subject affiliated or entitled to a social security scheme

排除标准

  • Minor patient
  • Refusal to participate
  • Patient under guardianship
  • Patient under guardianship

结局指标

主要结局

Number of contaminated personnel

时间窗: day 1

Number of contaminated personnel by occupational category and department on day 1.

次要结局

  • Number of contaminated personnel with effective protection(evolution at day 1, month 3 and month 6)
  • Number of contaminated personnel(month 6)
  • Number of symptomatic staff by occupational category and service(month 6)
  • comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies(month 6)

研究者

发起方
Tourcoing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (4)

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