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临床试验/NCT04481646
NCT04481646招募中不适用

The Efficacy and Feasibility of Face Mask Sampling for Hospitalised Adult Patients and Healthcare Workers With Suspected COVID-19

University of Leicester1 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2020年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
630
试验地点
1
主要终点
Comparison with Naso-pharyngeal swab

研究概览

简要总结

COVID-19 has become a global problem. There is an urgent need to improve the diagnosis and screening of patients and healthcare workers for COVID-19 in the UK. Mask based sampling is a method of detecting SARS-COV-2 (the virus responsible for COVID-19) in the breath of suspected COVID-19 patients or healthcare workers in the mask that they would wear in hospital. The investigators have previously demonstrated the utility of this method in other respiratory infections, such as tuberculosis.

This project aims to investigate the utility of mask-based sampling is a tool for the diagnosis and quantification of COVID-19 in breath and the implications in a healthcare setting using three cohorts of participants. Initially we will compare the amount of COVID-19 detected by mask sampling compared with standard nasopharyngeal swab, which is the current gold standard test, in patients who present to hospital with COVID-19 symptoms.

We will address the length of time COVID-19 is breathed out by people affected by the virus and the how infectious the virus is over time in a cohort of symptomatic healthcare workers who are isolating at home. This will allow us to understand how long someone stays infectious for and may have the potential to inform public health measures, for instance when healthcare workers can return to work or duration of isolation. Finally we will investigate asymptomatic carriage of COVID-19 by different healthcare workers in different areas of the hospital during a screening study. This will allow us to understand the extent of infection amongst healthcare workers and allow us to address hospital acquired transmission.

详细描述

In order to understand the utility of face mask sampling for the diagnosis of COVID-19 and the public health implications, three cohorts of participants will be asked to take part in this study. Each participant will be asked to wear a modified face mask containing strips of sampling material for up to one hour and undertake a nasopharyngeal (nose/throat) swab concurrently. Depending on which cohort the participants are recruited to, the number of these 'sampling sessions' will vary. Basic demographic and microbiological data will be collected for every participant.

Cohort 1:

Patients admitted to hospital with COVID-19 symptoms will be approached to undertake a face mask sample and nasopharyngeal swab at two time points 12 hours apart on a single day whilst in hospital. Medical records will be accessed for basic clinical, demographic and microbiological data.

Cohort 2:

Healthcare workers who have report COVID-19 symptoms will be asked to undertake a face mask sample and nasophayngeal swab on days 1,3,5,7,10,14 and 21 of the study, for part of which they will be quarantined at home.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Not requiring oxygen by face mask
  • o Patients admitted to hospital with suspected COVID-19
  • Or o Healthcare workers working within University Hospitals of Leicester, including those with and without symptoms suspicious of COVID-19.

排除标准

  • Participants requiring oxygen by face mask (i.e., Venturi, non rebreathe)
  • Participants with respiratory failure
  • Medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the study
  • Individuals who are unable to provide informed consent for themselves (i.e., individuals who lack capacity).

结局指标

主要结局

Comparison with Naso-pharyngeal swab

时间窗: 6 months

Newly diagnosed patients compare mask and swab samples taken at the same time

Mask out over time

时间窗: 12 months

SARS-COV-2 RNA quantification over time SARS-COV-2 RNA quantification over 21 days post diagnosis

mask as a screening tool in asymptomatic people

时间窗: 6 months

screening of asymptomatic healthcare workers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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