Covid19VOC-COVID-DiagNCT04614883
Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 Infection
A study testing Volatile Organic Compounds analysis and Canine odor detection of Volatile Organic Compounds in people with Covid19, run by Hopital Foch at 1 site in France.
Trial summary
In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Volatile Organic Compounds analysis and Canine odor detection of Volatile Organic Compounds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2020to 26 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients
- Patents anaged at the Foch Hospital for suspected COVID-19 and any other patient whose management requires diagnosis of SARS-CoV-2 infection
- Patients aged 18 or over;
- Patients Fluent in French ;
- Patients with a signed consent form;
- Patients with a health insurance plan.
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- Healthy volunteers
- Foch Hospital staff asymptomatic for SARS-CoV-2 infection;
- Aged 18 yor over;
- Fluent in french;
- with a signed consent form;
- With a health insurance plan.
Who cannot join
- Pregnant woman
- Patient deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in Patients Referred to the Emergency Reception Service for Suspected COVID-19 Infection: Diagnostic Value and for Rapid Screening
In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients.
The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.
Read more
Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study).
Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.
- Conditions
- Covid19
- Being tested
- Volatile Organic Compounds analysis, Canine odor detection of Volatile Organic Compounds
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volatile Organic Compounds analysisDevice
VOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry.
Canine odor detection of Volatile Organic CompoundsOther
VOC analysis in sweat by trained dogs.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic patients or Healthy volunteers | Other | Patient with no symptom of COVID-19 infection but for whom a PCR test needs to be done because he has been in contact with a COVID-19 positive person Receives: Device: Volatile Organic Compounds analysis; Other: Canine odor detection of Volatile Organic Compounds |
| Symptomatic patients with positive PCR | Other | Patients with symptoms of COVID-19 and whose PCR result is positive Receives: Device: Volatile Organic Compounds analysis; Other: Canine odor detection of Volatile Organic Compounds |
| Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks | Other | Patients with symptoms of COVID-19 and whose PCR result is negative at inclusion but presents a seroconversion within 4 to 8 weeks post inclusion Receives: Device: Volatile Organic Compounds analysis; Other: Canine odor detection of Volatile Organic Compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection
Comparison of variation of Volatile Organic Compound (VOC) profiles in exhaled air of patients between patients with symptoms suggestive of COVID and infection confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and those whose infection is ruled out based on the negativity of RT-PCR and clinical data
Measured: 1 day
Secondary outcomes (2)
Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat
The equivalences and differences in nature of VOCs associated with infection with SARS-CoV-2 between exhaled air and sweat.
Measured: 1 day
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)
Proportion of success in detecting samples from patients with symptoms suggestive of COVID and infection confirmed by PCR.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start21 Oct 2020
- Primary completion26 Feb 2021
- Study completion26 Feb 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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Salvator, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614883
- Sponsor's protocol ID
- 2020_0143
- Acronym
- VOC-COVID-Diag
- Status last verified
- Jun 2021
- First submitted
- 2 Nov 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in Patients Referred to the Emergency Reception Service for Suspected COVID-19 Infection: Diagnostic Value and for Rapid Screening
- ClinicalTrials.gov ID
- NCT04614883
- Acronym / sponsor ID
- VOC-COVID-Diag / 2020_0143
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 4 Nov 2020 (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.
In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients.
The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.
Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study).
Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic patients or Healthy volunteers | Other | Device: Volatile Organic Compounds analysis, Other: Canine odor detection of Volatile Organic CompoundsPatient with no symptom of COVID-19 infection but for whom a PCR test needs to be done because he has been in contact with a COVID-19 positive person |
| Symptomatic patients with positive PCR | Other | Device: Volatile Organic Compounds analysis, Other: Canine odor detection of Volatile Organic CompoundsPatients with symptoms of COVID-19 and whose PCR result is positive |
| Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks | Other | Device: Volatile Organic Compounds analysis, Other: Canine odor detection of Volatile Organic CompoundsPatients with symptoms of COVID-19 and whose PCR result is negative at inclusion but presents a seroconversion within 4 to 8 weeks post inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients
- Healthy volunteers
Key exclusion criteria (2 listed)
- Pregnant woman
- Patient deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Volatile Organic Compounds analysisVOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry. | Device | Asymptomatic patients or Healthy volunteers, Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks, Symptomatic patients with positive PCR |
| Canine odor detection of Volatile Organic CompoundsVOC analysis in sweat by trained dogs. | Other | Asymptomatic patients or Healthy volunteers, Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks, Symptomatic patients with positive PCR |
Primary outcome
Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection
Time frame: 1 day
Comparison of variation of Volatile Organic Compound (VOC) profiles in exhaled air of patients between patients with symptoms suggestive of COVID and infection confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and those whose infection is ruled out based on the negativity of RT-PCR and clinical data
2 secondary outcomes
Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat
Time frame: 1 day
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)
Time frame: 1 day
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 16 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Helene Salvator, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volatile Organic Compounds analysis and Canine odor detection of Volatile Organic Compounds in people with Covid19, run by Hopital Foch 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 12 inclusion and 2 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 16 Jun 2021. 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?
Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection (time frame: 1 day). 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 16 Jun 2021.