Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air (COVIDAIR)
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19 focused on measuring covid19 diagnostic, Proton Transfer Mass Spectrometer, exhaled air, rapid and non-invasive diagnosis
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).
Sites / Locations
- Centre de prélèvement COVID-19 HCL et Métropole de Lyon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Outpatients without hospitalisation criteria
Arm Description
Symptomatic and asymptomatic outpatient without hospitalisation criteria presenting in a COVID-19 screening centre of the Hospices Civils de Lyon
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04706039
Brief Title
Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
Acronym
COVIDAIR
Official Title
Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
May 21, 2021 (Actual)
Study Completion Date
May 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
covid19 diagnostic, Proton Transfer Mass Spectrometer, exhaled air, rapid and non-invasive diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outpatients without hospitalisation criteria
Arm Type
Experimental
Arm Description
Symptomatic and asymptomatic outpatient without hospitalisation criteria presenting in a COVID-19 screening centre of the Hospices Civils de Lyon
Intervention Type
Diagnostic Test
Intervention Name(s)
Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process
Intervention Description
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 Measure Information:
Title
Sensitivity of the COVID-19 diagnostic using the Vocus PTR-TOF process.
Description
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.
Time Frame
At the inclusion visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Centre de prélèvement COVID-19 HCL et Métropole de Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
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