NCT04649931已完成不适用
Study to Evaluate Whether Differences in Exhaled Breath Can be Identified Using Ion Mobility Spectrometry (IMS) in Subjects Tested Positive for SARS-CoV-2 Infection and Subjects Tested Negative
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 related volatile organic compounds (VOC)
研究概览
简要总结
Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath.
In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
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
- 否
入选标准
- •PCR (= Polymerase Chain Reaction) testing for SARS CoV-2 will be/has been performed in a timely manner of sampling exhaled breath or PCR test for SARS-CoV-2 was performed within 96 hours, but preferably within 48 hours before sampling exhaled breath and PCR test result is already available
- •Subject must be able to comply with study-specific procedures, e.g.is able to comply with breathing commands
排除标准
- •Previous (history) SARS-CoV-2 infection, independent of the current episode
- •Participation in a therapeutic study prior to breath analysis which could influence the result of the breath analysis
结局指标
主要结局
SARS-CoV-2 related volatile organic compounds (VOC)
时间窗: 1 hour after breath gas sampling
次要结局
- To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019)(within 1 hour)
研究者
研究点 (1)
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