Screening for SARS-CoV-2-Infections and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,092
- 试验地点
- 1
- 主要终点
- Number of people with detectable antibodies to SARS-CoV-2
研究概览
简要总结
The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2, e.g. to assess vaccination effects
详细描述
This study aims to collect information on staff working at the Greifswald University hospital.
Over a 5 year period, a maximum of 12 study visits per participant are planned. At each visit, nasal/throat swabs (for PCR testing) and/or blood samples (to assess immunological responses, e.g. for SARS-CoV-2 antibody testing) will be collected. This will help to gain a better understanding of viral load and immunological responses, e.g. antibody development and their effects over time.
At study visit 2 - 12, participants will also be asked to fill in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, impact of the pandemic on their quality of life, their interest in getting a SARS-CoV-2 vaccine/their SARS-CoV-2 vaccination status and vaccination side effects).
The remaining blood samples will be stored in a repository for future research.
The study is part of a modular SARS-CoV-2-research programme of the University Medicine Greifswald.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>= 18 years of age
- •Willing and able to complete a written consent form
- •Willing to have blood samples stored for future research
- •Healthcare worker employed at Greifswald University Hospital
排除标准
- •< 18 years of age
- •Decline to participate
结局指标
主要结局
Number of people with detectable antibodies to SARS-CoV-2
时间窗: 1 year
Anti-SARS-CoV-2 S protein IgG ELISA/ Anti-SARS-CoV-2 NCP IgG ELISA
次要结局
- Number of people with detectable SARS-CoV-2 nucleic acid(First study visit (baseline))