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临床试验/NCT04426292
NCT04426292
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不适用

SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 3,500 人2020年5月12日
适应症Sars-CoV2

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Sars-CoV2
发起方
Universitair Ziekenhuis Brussel
入组人数
3500
试验地点
1
主要终点
Seroprevalence
最后更新
4年前

概览

简要总结

A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19).

This study is a monocentric interventional prospective cohort study. After signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. Sample storage and analysis will be performed at the laboratory of microbiology of the UZ Brussel.

  • To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5.
  • To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.
注册库
clinicaltrials.gov
开始日期
2020年5月12日
结束日期
2021年12月25日
最后更新
4年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Any adult employee of the UZ Brussel who provided a signed informed consent to participate in the study.

排除标准

  • UZ Brussel employees whose contract expires within 6 months of study initiation, with the exception of resident trainees (if training continues in another hospital, resident trainees will be asked to perform the last sampling when leaving the UZ Brussel).
  • Staff not active during the inclusion period

结局指标

主要结局

Seroprevalence

时间窗: Change from baseline to 2 months and 5 months timepoint

- To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5.

seroconversions

时间窗: Change from baseline to 2 months and 5 months timepoint

- To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.

次要结局

  • Incidence of probable cases(Change from baseline to 2 months and 5 months timepoint)
  • Incidence of definite cases(Change from baseline to 2 months and 5 months timepoint)
  • Antibody kinetics(Change from baseline to 2 months and 5 months timepoint)
  • Proportion of asymptomatic seroconversions(Change from baseline to 2 months and 5 months timepoint)
  • Concerns for safety for infection with COVID-19(Change from baseline to 2 months and 5 months timepoint)
  • Potential work-related risk factors(Change from baseline to 2 months and 5 months timepoint)

研究点 (1)

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