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临床试验/NCT04431310
NCT04431310招募中不适用

Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic

Nordsjaellands Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
2
主要终点
Serology testing for specific COVID-19

研究概览

简要总结

The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital. This will enable the identification of those who are protected and non-infectious for SARS-CoV2 and those who are seronegative and therefore potentially susceptible and infectious on patient contact. Prospective testing will provide data on the acquisition of SARS-CoV2 infections among HCWs and associated risk factors for transmission during a pandemic at an acute care hospital facility in the capital region of Denmark.

Hypothesis: Serial seroconversion measurements in hospital employees improve the organization of the clinical treatment and care during the COVID-19 pandemic at Nordsjællands Hospital and Nykøbing Falster County Hospital.

详细描述

The study is a prospective cohort study. Weekly (in the first phase) and bi-weekly (in the second phase) serum samples will be drawn and shipped bi-weekly to laboratory collaborators in United Kingdom for antibody analyses during the course of the local epidemic, expected to last 10-12 weeks or more. After the cease of the epidemic serum will be drawn in 3-monthly intervals in a smaller group of seroconverted volunteers to follow the long-lasting immunity of SARS-CoV-2 infection up to 5 years post-pandemic.

Nurses, medical doctors, biomedical laboratory scientists, social health care assistants, and few healthcare administrators (as controls) will be invited for enrolment. In hospitals, all departments with staff that are in physical contact with patients during the pandemic will be invited to participate in the study.

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

入选标准

  • hospital employee

排除标准

  • 未提供

结局指标

主要结局

Serology testing for specific COVID-19

时间窗: From baseline to follow up at four years

IgM and IgG (Covid-19 antibodies)

次要结局

  • SARS-CoV-2 infection(From baseline to follow up at three months)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thea Kølsen Fischer

Professor

Nordsjaellands Hospital

研究点 (2)

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