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临床试验/NCT04475562
NCT04475562已完成不适用

Can the Electronic Nose Smell COVID-19? A Proof-of-principle Study

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2020年4月6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
219
试验地点
2
主要终点
COVID 19 positive vs negative

研究概览

简要总结

Infection with SARS-CoV-2 causes Corona Virus Disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigates the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19 positive- and negative persons based on volatile organic compounds (VOCs) analysis.

Methods: between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, presence of SARS-CoV-2 specific antibodies was checked to confirm the negative result. All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. The result is a value between -1 and +1, indicating the infection probability.

研究设计

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

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

  • Participants of whom an oropharyngeal or nasopharyngeal swab was collected to perform RT-PCR on.

排除标准

  • Participants who were experiencing dyspnea or needed supplemental oxygen.

结局指标

主要结局

COVID 19 positive vs negative

时间窗: 3 months

Ability of the eNose to distinguish COVID-19 positive from COVID-19 negative persons based on VOC patterns.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole Bouvy

Prof. Dr. Nicole D. Bouvy

Maastricht University Medical Center

研究点 (2)

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