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临床试验/NCT04508556
NCT04508556已完成不适用

Performance Assessment of SARS-CoV-2 Detection Through Analysis of Exhaled Breath Aerosols

Owlstone Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Positive control for technical validation

研究概览

简要总结

The primary aim of this study is to investigate the performance of Breath Biopsy RD for the detection of SARS-CoV-2 in both a clinical and at home setting.

详细描述

This study aims to evaluate Owlstone Medical's Breath Biopsy RD Collectors for the detection of SARS-CoV-2 infection. These single use disposable breath capture devices can be used independently by individuals and shipped to be analysed in a central lab for the presence of SARS-CoV-2 using established existing PCR assays available in any reference lab. The aerosol collectors furthermore directly sample exhaled breath aerosols. As such they directly sample the primary transmission route for the virus. This could result in a higher rate of retrieval of viral RNA in infected individuals thereby increasing the sensitivity of the applied PCR assay. This is underpinned by the fact that CT abnormalities in the lower airways appear to occur prior to upper respiratory tract samples becoming positive in cases suffering from nCOVID19, suggesting lower airway viral loads could be higher. Combined, this could enable more widespread access to diagnostics, reduce the need for repeat testing, decrease the need for healthcare professionals to perform diagnostic tests and reduce cross-contamination risk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Any adult >18 years with either a confirmed (phase 1) or suspected (phase 2&3) SARS-CoV-2 infection will be eligible to participate in this study.

排除标准

  • Subject who are deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds
  • Subject who require non-invasive ventilation or high flow nasal oxygen
  • Subject who require inotropic medication to maintain adequate organ perfusion
  • Subject who have a communication barrier and / or unable to comply with the instructions to use the Breath Biopsy test

结局指标

主要结局

Positive control for technical validation

时间窗: 1 year

The purpose of this stage is to confirm the optimal extraction protocol to detect the presence of SARS-CoV-2 from the aerosols captured in the Breath Biopsy RD device. Up to two Breath Biopsy RD sample will be collected alongside a nasopharyngeal. The swab obtained during this stage is to be analysed in parallel to the extracted breath aerosols in the lab of the lab and will be used as a positive control.

次要结局

  • Evaluation of test performance(1 year)

研究者

发起方
Owlstone Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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