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临床试验/NCT04453280
NCT04453280已完成不适用

Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)

Institute of Health Information and Statistics of the Czech Republic1 个研究点 分布在 1 个国家目标入组 695 人开始时间: 2020年5月18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
695
试验地点
1
主要终点
Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients.

研究概览

简要总结

The aim of the SARS-CoV-2-CZ-Immunity study is to determine the time profile of the presence of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or performing a rapid test in COVID-19 cured patients.

详细描述

COVID-19 is caused by a new type of coronavirus called SARS-CoV-2. It is a highly infectious disease, manifested mainly by fever, respiratory problems, muscle pain, and fatigue. However, despite the publication of hundreds of papers in the literature, fundamental information about the spread and course of the disease is still lacking in COVID-19. One of such key information is the time profile of the presence of antibodies against SARS-CoV-2 after the disease.

The SARS-CoV-2-CZ-Immunity study is aiming at the determination of the time profile of the presence of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or performing a rapid test in COVID-19 cured patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • signed Informed Consent
  • residing in Prague, Central Bohemian Region or South Moravian Region
  • demographic criteria: persons aged 8-17 and persons aged 18 and more
  • clinical criteria: (i) diagnosis of COVID-19 confirmed by PCR (ii) cured patients: clearance of SARS-CoV-2 viral RNA demonstrated by two consecutive negative RT-PCR results (iii) without acute health problems

排除标准

  • 未提供

结局指标

主要结局

Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients.

时间窗: May 2020

The primary outcome is the determination of the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes in relation to the categories of cured patients according to the time from the date of cure from the COVID-19 disease to the date of examination.

次要结局

  • Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the age and to the severity of the disease.(June 2020)
  • The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies.(June 2020)

研究者

发起方
Institute of Health Information and Statistics of the Czech Republic
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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