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临床试验/NCT04446338
NCT04446338Unknown不适用

Immune Status: Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Sample of the Eye Department (University Eye Hospital and Research Institute Tübingen)

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年5月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Seroprevalence

研究概览

简要总结

A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The protocol included a rapid test and several ELISA tests within a defined cohort of healthcare workers.

详细描述

In the current pandemic, the assessment of actual COVID-19 infections plays an important role in the assessment of the risk and progress of the epidemic. Shortly, more and more rapid tests will be available, the aim of which is to be able to obtain a good overview of the immune status of corresponding samples in a timely manner.

Employees in the health sector are faced with additional challenges, not only due to the tightened hygiene regulations. The concern about infecting other people and/or exposing oneself to a relevant health risk is of great importance. A moderate to high transmission risk can be assumed for ophthalmology. In view of older patients and sometimes unavoidable proximity, targeted and reliable diagnostics can offer the potential to reduce the risk potential for the current situation by determining antibodies.

A rapid diagnosis is not yet available outside of clinical studies, especially since deficits in specificity (contact with other coronaviruses) are to be expected. Studies on the serological reaction are not yet available for longer observation periods, but it can be assumed that positive direct detection of IgG (Anti Sars-CV-2-ELISA; Euroimmun) is available at the latest 3 weeks after the onset of symptoms. Without larger and representative analyses, it is currently unclear whether seroconversion is associated with permanent immunity or a lack of it leads to a possible susceptibility to reinfection. A combined test procedure is therefore to be offered to employees within the framework of a random sample.

The query of anamnestic parameters allows the assignment to different groups (CC: past COVID infection, PC: possible infection, N: asymptomatic). The primary goal of the planned study is to provide a first preliminary evaluation of the tests used in the current context.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Employees of the health facility described
  • voluntary request for testing

排除标准

  • 未提供

结局指标

主要结局

Seroprevalence

时间窗: through study completion, maximum of one year

Rate of anti-SARS-CoV-2 Antibodies

次要结局

  • Agreement of the test results and questionnaire(through study completion, maximum of one year)
  • Positive predictive / negative values of the tests applied(through study completion, maximum of one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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