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临床试验/NCT04637867
NCT04637867已完成不适用

Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study

Hospices Civils de Lyon4 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2020年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
4
主要终点
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients

研究概览

简要总结

There are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with SARS-CoV-2. Serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. The nature of the immune response induced by this virus is also poorly understood. This ancillary study aims at assessing the immunological characteristics of patients that participated in the NOSO-COR study at Hospices Civils de Lyon six and twelve months after the initial infectious episode.

Two visits will be scheduled at 6 and 12 months (± 1 month) after the initial SARS-CoV-2 infectious episode, Blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • SARS-CoV-2 confirmed by RT-PCR
  • Adults > 18 years
  • Signed consent form
  • Affiliated to the French health system

排除标准

  • Pregnant women
  • Hospitalized patients
  • Individuals subject to legal protection
  • Imprisoned individuals
  • Individuals who have expressed an opposition to participate, or who do not wish to donate blood samples

结局指标

主要结局

Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients

时间窗: Month 12

To describe the immune response to SARS-CoV-2 infection by measuring the level of IgG and IgM in the blood of patients 12 months after laboratory-confirmed diagnosis of SARS-CoV-2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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