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Trial record 1 of 62 for:    Covid19 | Lyon, France
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Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air (COVIDAIR)

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ClinicalTrials.gov Identifier: NCT04706039
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Covid19 Diagnostic Test: Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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.





Primary Outcome Measures :
  1. Sensitivity of the COVID-19 diagnostic using the Vocus PTR-TOF process. [ Time Frame: 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.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706039


Contacts
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Contact: Alexandre GAYMARD, MD 04.72.07.10.53 alexandre.gaymard@chu-lyon.fr
Contact: Christian GEORGE, MD 04.72.44.81.90 Christian.George@ircelyon.univ-lyon1.fr

Locations
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France
Centre de prélèvement COVID-19 HCL et Métropole de Lyon Recruiting
Lyon, France, 69000
Contact: Alexandre GAYMARD, MD    04.72.07.10.53    alexandre.gaymard@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04706039    
Other Study ID Numbers: 69HCL20_1148
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
covid19 diagnostic
Proton Transfer Mass Spectrometer
exhaled air
rapid and non-invasive diagnosis