Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air (COVIDAIR)

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process

• Study Type: Interventional
• Enrollment (Actual): 4600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69000
    • Centre de prélèvement COVID-19 HCL et Métropole de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Outpatients without hospitalisation criteria; Symptomatic and asymptomatic outpatient without hospitalisation criteria presenting in a COVID-19 screening centre of the Hospices Civils de Lyon

Diagnostic test: Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process; Each patient will be sampled to do a systematic respiratory virus infection screening (SARS-CoV-2 and Flu and RSV). Then each patient will be tested using the Vocus PTR-TOF process. A self-answering questionnaire will be used to collect symptomatology information and date of onset of symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the COVID-19 diagnostic using the Vocus PTR-TOF process.	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.	At the inclusion visit

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 21, 2021
• Study Completion (Actual): May 21, 2021

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: covid19 diagnostic; Proton Transfer Mass Spectrometer; exhaled air; rapid and non-invasive diagnosis
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 69HCL20_1148

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No