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临床试验/NCT04346264
NCT04346264已完成不适用

CoVid-19 - Infection and Antibody Formation in the Viennese Population - Data From the Vienna Health Study LEAD

Ludwig Boltzmann Institute for Lung Health1 个研究点 分布在 1 个国家目标入组 12,419 人开始时间: 2020年4月27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
12,419
试验地点
1
主要终点
Prevalence of SARS-CoV-2 antibody titres

研究概览

简要总结

Summary of the study

Study population:

A representative sample of the Viennese population stratified by age and gender (data from the Vienna Health Study LEAD)

Potential output and analysis:

  • Extent of age-specific infection and antibody formation
  • Cumulative incidence of infection
  • Rate of asymptomatic infection
  • Relationship with socioeconomics, lifestyle and risk factors (comorbidities)

Study design:

Prospective, longitudinal, stratified by age and gender

Duration of study:

Initial testing as soon as possible and repeat based on monitoring of the pandemic curve (probably after 2-3 months)

Information to be obtained from participants:

  • serum samples for information on SARS-CoV2 infection and antibody formation
  • data on clinical symptoms

详细描述

Both international (WHO; (1) and national are calling for increased testing for the SARS-CoV-2 virus; at present it is completely unclear how many people will actually become infected with the Covid-19 virus or have formed antibodies against it during the pandemic. The greatest uncertainty of all calculation models on hospitalisation rates, morbidity and mortality of the pandemic is the unknown number of unreported cases of citizens infected or having been infected with Covid-19.

Currently the direct detection of the SARS-CoV-2 virus from the mouth/nose/throat swab using PCR is established worldwide with high sensitivity and specificity. This direct method is expensive and not always available in sufficient quantities. Furthermore, the results are strongly influenced by the quality of the smear collection.

The detection of antibodies against the SARS-CoV-2 virus is an alternative method for determining whether a person has been infected with SARS-CoV-2 and has developed an immune response to the virus. Recently several companies have been offering such kits for sale. According to national experts, these kits have not yet been sufficiently clinically validated, which is why valid data on their sensitivity and specificity are not yet available. However, on the validation of these tests are being worked hard all over the world, so that it can be assumed (the experts also agree on this) that data on the sensitivity and specificity of the antibody tests will be available in the foreseeable future.

Probably the only reasonable and feasible method of testing the actual rate of Covid-19 infection in a given population is to detect infection (either directly or indirectly by means of antibody testing) from a sample that is as representative as possible for this population.

The selected subjects of the LEAD study, the core project of the Ludwig Boltzmann Institute for Lung Health at Otto Wagner Hospital (the hospital association is an official partner of the institute), represent an exemplary representative sample of the general population in Vienna (i.e. the sample corresponds to the Viennese population in terms of age, gender, smoking habits, place of residence, etc.). In the LEAD study, more than 11,000 subjects (aged 6-80) mainly from Vienna were subjected to a "Health examination survey" (2).

研究设计

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

入排标准

年龄范围
6 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •all participants of the Austrian LEAD study will be invited (www.leadstudy.at) -

排除标准

  • •pregnancy, failure due to language

结局指标

主要结局

Prevalence of SARS-CoV-2 antibody titres

时间窗: 5 weeks

Antibody Titres IgG and IgM

次要结局

  • Prevalence of SARS-CoV-2 antibody titres after 3 Months(4 Months)

研究者

发起方
Ludwig Boltzmann Institute for Lung Health
申办方类型
Other
责任方
Sponsor

研究点 (1)

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