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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process

• Registration Number: NCT04706039
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-12
• Study Start: 2021-03-01
• Primary Completion: 2021-05-21
• Study Completion: 2021-05-21
• Status Verified: 2021-07
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4600

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Outpatients without hospitalisation criteria	Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process	Symptomatic and asymptomatic outpatient without hospitalisation criteria presenting in a COVID-19 screening centre of the Hospices Civils de Lyon

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centre de prélèvement COVID-19 HCL et Métropole de Lyon; 🇫🇷 Lyon, France