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临床试验/NCT04490837
NCT04490837已完成不适用

Rapid Diagnostic Test for COVID-19 Based on Antibody Detection

Corporacion Parc Tauli1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2020年6月22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
3,500
试验地点
1
主要终点
IgG anti-COVID-19

研究概览

简要总结

Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices. This test will be developed using innovative technology developed at the Parc Taulí University Hospital, which increases the immunogenicity of SARS-CoV-2 differential antigens. The increased immunogenicity of these antigens will allow to detect, with a high sensitivity and specificity, the antibodies in the serum of patients infected with SARS-CoV-2. This test will serve to confirm dubious results as well as reduce false negatives from the PCR test, which will ultimately help reduce transmission of the infection.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Professional from Parc Taulí University Hospital
  • Patients with clinical, radiological and/or PCR COVID-19 positive

排除标准

  • Patients or professionals who do not sign informed consent

结局指标

主要结局

IgG anti-COVID-19

时间窗: From May to July

IgG antibodies against COVID-19 RBD

IgM anti-COVID-19

时间窗: From May to July

IgM antibodies against COVID-19 RBD

IgA anti-COVID-19

时间窗: From May to July

IgA antibodies against COVID-19 RBD

次要结局

  • COVID-19 PCR results(From May to July)
  • Time of onset symptoms(From May to July)
  • Radiological studies(From May to July)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Francisco Delgado de la Poza

Senior Medical Doctor

Corporacion Parc Tauli

研究点 (1)

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