Covid19COVIDAIRNCT04706039
Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
A study testing Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process in people with Covid19, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 21 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major subject under guardianship or curatorship or unable to consent to study.
- Subject under safeguard of justice
- Minor patient (age < 6 years).
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de prélèvement COVID-19 HCL et Métropole de Lyon
Lyon, 69000
About this study
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:
Read more
- 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:
- 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:
- 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.
- Conditions
- Covid19
- Being tested
- Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process
- Keywords
- covid19 diagnostic, Proton Transfer Mass Spectrometer, exhaled air, rapid and non-invasive diagnosis
- Medical subject headings
- COVID-19, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF processDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Outpatients without hospitalisation criteria | Experimental | Symptomatic and asymptomatic outpatient without hospitalisation criteria presenting in a COVID-19 screening centre of the Hospices Civils de Lyon Receives: Diagnostic Test: Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Mar 2021
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706039
- Sponsor's protocol ID
- 69HCL20_1148
- Acronym
- COVIDAIR
- Status last verified
- Jul 2021
- First submitted
- 8 Jan 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
- ClinicalTrials.gov ID
- NCT04706039
- Acronym / sponsor ID
- COVIDAIR / 69HCL20_1148
- Conditions
- Covid19
- Keywords
- covid19 diagnostic, Proton Transfer Mass Spectrometer, exhaled air, rapid and non-invasive diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,600 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients without hospitalisation criteria | Experimental | Diagnostic Test: Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF processSymptomatic and asymptomatic outpatient without hospitalisation criteria presenting in a COVID-19 screening centre of the Hospices Civils de Lyon |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Major subject under guardianship or curatorship or unable to consent to study.
- Subject under safeguard of justice
- Minor patient (age < 6 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF processEach 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. | Diagnostic test | Outpatients without hospitalisation criteria |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process in people with Covid19, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the COVID-19 diagnostic using the Vocus PTR-TOF process. (time frame: At the inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.