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