Clinical trial NCT04706039: Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
Official title: Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: covid19 diagnostic
Proton Transfer Mass Spectrometer
exhaled air
rapid and non-invasive diagnosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 4600
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Sensitivity of the COVID-19 diagnostic using the Vocus PTR-TOF process.
timeFrame: At the inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de prélèvement COVID-19 HCL et Métropole de Lyon
Study officials:
References: