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临床试验/NCT04475575
NCT04475575已完成不适用

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

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 222 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
222
试验地点
2
主要终点
COVID-19 antibodies vs COVID-19 negative

研究概览

简要总结

Corona Virus Disease (COVID-19), spread worldwide and has become an emergency of major international concern. In March 2020, the WHO declared the COVID-19 outbreak a global pandemic. Accurate and fast diagnosis is crucial in managing the pandemic. Current diagnostic approaches raise several difficulties: they are time-consuming, expensive, invasive, and most important lacking high sensitivity. The gold standard diagnostic test for COVID-19, reverse transcription polymerase chain reaction (RT-PCR), is highly dependent on adequate deep sampling of the swab in the naso- and oropharynx. A new diagnostic test that can correctly and rapidly identify infected patients and asymptomatic carriers is urgently required to prevent further virus transmission and thus reduce mortality rates.

Aim: This proof-of-principle study aims to investigate if an electronic nose (Aeonose) can distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs).

Methods: between April and July 2020, persons undergoing RT-PCR and a serology test for COVID-19 were recruited at Maastricht UMC+ for breath analysis. All participants had to breathe through the Aeonose for five consecutive minutes. The VOC pattern in their exhaled breath was then linked to the matching RT-PCR and serological test results.

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 and nasopharyngeal swab was collected for RT-PCR and on whom serology testing for the detection of antibodies was performed.

排除标准

  • Participants who where experiencing dyspnea or needed supplemental oxygen.

结局指标

主要结局

COVID-19 antibodies vs COVID-19 negative

时间窗: 3 months

Ability of the electronic nose (Aeonose) to distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs).

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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