COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44,698
- 试验地点
- 14
- 主要终点
- Comparison of the point of care test and Elisa
研究概览
简要总结
During the COVID-19 pandemic several countries have seen a high risk of transmission for health care personnel, with some countries having as many 20-25% of nurses and doctors either infected or showing symptoms of COVID-19.
In this prospective cohort study, we will systematically screen all hospital staff in the Capital Region of Denmark for IgM and IgG antibodies against SARS-CoV-2 using a point of care tests and an Elisa kit.
Testing will be offered 3 times: In April 2020, Maj 2020 and September 2020. All participants will submit a questionnaire regarding exposures, risk factors and symptoms of COVID-19 in relation to each testing. Follow-up will be through electronic patient records and national registries.
We will compare the group of health care personnel with data from a control group of healthy volunteer blood donors from the Danish Blood Donor Study.
The aim of the study is to investigate the proportion of hospital staff with SARS-CoV-2 antibodies during the study period compared to a control group representing the Danish population. We will compare the test characteristics of the two methods of testing, a point of care test and Elisa.
Further, we will investigate the extent to which prior immunization or infection is protective for future infection with COVID-19.
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
- 否
入选标准
- •>18 years old
- •Consent to participation
- •Employed at a Hospital in the Capitial Region of Denmark
排除标准
- 未提供
结局指标
主要结局
Comparison of the point of care test and Elisa
时间窗: 5 months
Comparison of the resultat from the point of care test and with results from Elisa
Re-infection rate
时间窗: 360 days
Number of patients, who were tested positive for antibodies on an earlier test and later are infected with COVID-19
Positive IgM/IgG tests
时间窗: 5 month
Proportion of hospital staff who have a positive IgM/IgG tests for antibodies to SARS-CoV-2 on point of care test and/or Elisa compared to the background population
IgM/IgG positive participants on follow-up test
时间窗: 5 months
Proportion of IgM/IgG positive participants with a lasting immune response. This will be the participants who are still positive on follow-up
次要结局
未报告次要终点