跳至主要内容
临床试验/NCT04706039
NCT04706039已完成不适用

Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 4,600 人开始时间: 2021年3月1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
4,600
试验地点
2
主要终点
Sensitivity of the COVID-19 diagnostic using the Vocus PTR-TOF process.

研究概览

简要总结

Since the start of 2020, the new SARS-CoV-2 coronavirus is causing a real global health crisis.

In France, nasopharyngeal swabs are used to obtain the sample needed for respiratory infection screening. There are three major difficulties with this type of sampling:

I) It is really unpleasant for the patient because the device has to be pushed into the nostril to reach the nasopharynx. It causes some patients to bleed or even feel uncomfortable.

II) It is not easily accepted by children. III) It is dependent on the availability of swabs. Faced with these difficulties linked to the initial sampling, new methods are being studied to enable a rapid and non-invasive diagnosis of COVID-19 based on the instantaneous identification of metabolites or volatile organic compounds (VOCs).

Due to their sensitivity and the wealth of information that can be provided, the most promising techniques are based on mass spectrometry coupled with a soft ionisation system. For example, on-line exhaled air analysis is capable of detecting a very large number of VOCs. Various tests on metabolites in the exhaled air have already been carried out without being totally conclusive because the existing instruments suffer from various limitations:

I) poor repeatability/accuracy in the chemical characterisation of exhaled air ; II) too high specificity (detection of only part of the emitted compounds); III) too limited sensitivity; IV) and poor adaptation to be deployed in a clinic.

In order to overcome these various limitations, we propose the use of a new generation of mass spectrometer: Vocus PTR-TOF. The Vocus PTR-TOF is a Proton Transfer Mass Spectrometer (PTR-MS) developed for the detection, in real time, of trace VOCs in industrial environments, laboratories or directly in the environment. This new generation of instrument offers the following advantages:

I) unequalled sensitivity :

II) a robust ionisation system not affected by environmental conditions (relative humidity...) ; III) a high mass resolution allowing precise identification of compounds ; IV) a compact and durable architecture allowing deployment in a constrained environment such as hospital, airport... The sensitivity and speed of measurement allow the expiration process to be monitored in real time, bringing an additional dimension to the measurement and the chances of success.

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

入选标准

  • Symptomatic and asymptomatic outpatient without hospitalisation criteria
  • No medical contraindications to nasopharyngeal swabbing (deviation of the nasal septum, epistaxis, anticoagulant treatment).
  • Patient able to blow into the test device
  • Patients or parents with parental authority who have been informed of the study and have not objected to participating in it

排除标准

  • Major subject under guardianship or curatorship or unable to consent to study.
  • Subject under safeguard of justice
  • Minor patient (age < 6 years).

结局指标

主要结局

Sensitivity of the COVID-19 diagnostic using the Vocus PTR-TOF process.

时间窗: At the inclusion visit

Study of the sensitivity of the exhaled air test in comparison to the reference diagnostic RT-PCR on nasopharyngeal swab. We will use the results of the RT-PCR as reference to compare the results of the Vocus PTR-TOF process.

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 (2)

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