跳至主要内容
临床试验/NCT04341142
NCT04341142进行中(未招募)不适用

Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2020年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
550
试验地点
2
主要终点
The positivity (Yes/No) of the serological test.

研究概览

简要总结

Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests

研究设计

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

  • Seropositive caregivers screened for anti-SARS CoV2 antibodies during their consultation at the occupational medicine of HCL.
  • Age: ≥ 18 years old
  • Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
  • Persons affiliated to a social security scheme or beneficiary of such a scheme.

排除标准

  • Pregnant or lactating woman

结局指标

主要结局

The positivity (Yes/No) of the serological test.

时间窗: Day 42

The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

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 (2)

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