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临床试验/NCT04527432
NCT04527432已完成不适用

A Pilot Assessment of the COVID-19 Antibody Status and Associated Factors, in Individuals Employed by a Large Acute NHS Trust During the Coronavirus Pandemic

The Royal Wolverhampton Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 1,504 人开始时间: 2020年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,504
试验地点
2
主要终点
The number of employees tested who have evidence of SARS-CoV-2 antibodies

研究概览

简要总结

The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources and staff in the UK. Understanding the key risk factors associated with infection amongst healthcare workers is essential for future pandemic response plans.

Currently there are scarce data relating to the infection rates and associated factors amongst healthcare workers in the United Kingdom (UK). Studies of infection rates in healthcare workers have largely relied on the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice as likely to succumb to Coronavirus infection, when compared to the general population and those from Black and minority ethnic (BAME) backgrounds appear to be particularly at risk.

Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibodies provides seasonal or long term immunity to future infection.

Therefore, this study aims to understand the current level of SARS-CoV-2 antibody positivity and try to determine the likely risk to healthcare workers in the UK to COVID-19 infection. This study hopes to find out whether certain individual characteristics will have an impact on likelihood of infection susceptibility and antibody response and determine the impact of the presence of antibodies on the likelihood of future clinical infection over a 12 month period.

The study involves an initial online survey and linkage to the recent antibody test, then a further online survey in 6 and 12 months' time. The data obtained will be linked to data that the Human Resources Department (HR) holds.

Participants also have the option to partake in another antibody test at 6 and 12 months' time and linked to the data collected.

详细描述

Participants will have access to the study via the link given in an SMS (Short Message Service - text message) which will direct then to the first online survey.

They will then be contacted again in 6 and 12 months' time to complete the online survey again.

The survey answers will be linked to the results of the antibody tests by their mobile and Employment Number and also to data held about them by the HR Department.

The survey will take approximately 15 minutes to complete and will include questions on the following: profession; work-line type; demographics and behavioural factors; ethnicity; and symptoms (if COVID 19 was manifested).

Participants can also attend for another blood test (SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody test) to detect any presence of antibodies at 6 and 12 months (optional) which will again be linked to the survey and HR data.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • All Staff employed by Royal Wolverhampton Trust, having undergone the SARS-CoV-2antibody test at the Trust's testing facility

排除标准

  • Royal Wolverhampton NHS Trust staff who have not participated in antibody testing • Staff who have opted out to receiving the text message invite and be part of the study

结局指标

主要结局

The number of employees tested who have evidence of SARS-CoV-2 antibodies

时间窗: 12 months

evidence of SARS-CoV-2 antibodies

Factors associated with a positive test

时间窗: 12 months

Survey to establish * Type of healthcare role * Ethnicity * Age * Index of multiple deprivation * Previous RT-PCR test status * Previous clinical COVID infection * Previous period of self isolation * Level of COVID-19 related anxiety * Presence of one or more high risk factors for COVID 19 * Presence or absence of self-reported COVID 19 symptoms

Likelihood of clinically relevant (causing illness) infection with SARS-CoV-2 in subjects with both positive and negative SARS-CoV-2 antibody tests

时间窗: 12 months

Infection compared to antibody presence

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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