Covid19VOCSARSCOVDepNCT04817371
Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for COVID-19 Infection.
A study testing Volatile Organic Compounds analysis (e-noses), Canine odor detection of Volatile Organic Compounds and Volatile Organic Compounds analysis (mass spectrometry) 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 olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Volatile Organic Compounds analysis (e-noses), Canine odor detection of Volatile Organic Compounds and Volatile Organic Compounds analysis (mass spectrometry)
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to Sep 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject included in the Foch Hospital :
- Patients managed at the Foch Hospital with RT-PCR screening for SARS-CoV-2 infection
- Healthy volunteers among the hospital staff, asymptomatic, for whom an RT-PCR SARS-CoV-2 is indicated or recommended.
- Healthy hospital volunteers vaccinated against COVID (full vaccination schedule completed)
- At least 18 years of age;
- Fluency in the French language;
- Have signed a consent form;
- Be affiliated 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.
France1 site, 1 recruiting
- Recruiting
Foch hospital
Suresnes, 92151
Philippe Devillier, PhD, 0146252791, p.devillier@hopital-foch.com
Hélène Salvator, MD, 0146252955, h.salvator@hopital-foch.com
About this study
Official title: Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for SARS-CoV-2 Infection.
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 (e-noses), Canine odor detection of Volatile Organic Compounds, Volatile Organic Compounds analysis (mass spectrometry), Volatile Organic Compounds analysis in sweat (mass spectrometry)
- 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 analysis (e-noses)Device
VOC analysis in exhaled air with e-noses.
Canine odor detection of Volatile Organic CompoundsOther
VOC analysis in sweat by trained dogs.
Volatile Organic Compounds analysis (mass spectrometry)Device
VOC analysis in exhaled air with mass spectrometry.
Volatile Organic Compounds analysis in sweat (mass spectrometry)Device
VOC analysis in sweat with mass spectrometry.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic patients with positive PCR | Other | Patients with symptoms of COVID-19 and whose PCR result is positive Receives: Device: Volatile Organic Compounds analysis (e-noses); Other: Canine odor detection of Volatile Organic Compounds; Device: Volatile Organic Compounds analysis (mass spectrometry); Device: Volatile Organic Compounds analysis in sweat (mass spectrometry) |
| Symptomatic patients with positive PCR for other respiratory virus | Other | Patients with symptomatic respiratory disease of infectious origin with negative RT-PCR for SARS-CoV-2 and positive RT-PCR for other respiratory viruses Receives: Device: Volatile Organic Compounds analysis (e-noses); Other: Canine odor detection of Volatile Organic Compounds; Device: Volatile Organic Compounds analysis (mass spectrometry); Device: Volatile Organic Compounds analysis in sweat (mass spectrometry) |
| Asymptomatic patients or healthy volunteers | Other | Patients or healthy volunteers with negative RT-PCR and negative serology Receives: Device: Volatile Organic Compounds analysis (e-noses); Other: Canine odor detection of Volatile Organic Compounds; Device: Volatile Organic Compounds analysis (mass spectrometry); Device: Volatile Organic Compounds analysis in sweat (mass spectrometry) |
| Volunteers or patients vaccinated against COVID-19 | Other | Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme) Receives: Device: Volatile Organic Compounds analysis (e-noses); Other: Canine odor detection of Volatile Organic Compounds; Device: Volatile Organic Compounds analysis (mass spectrometry); Device: Volatile Organic Compounds analysis in sweat (mass spectrometry) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first co-objective of this experimental study is to determine if VOCs analyzed by electronic noses are of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by electronic noses) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID-19 and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
Measured: 1 day
The second co-objective of this experimental study is to determine if VOCs analyzed by mass spectrometry is of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by mass spectrometry) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
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 identified by mass spectrometry.
Measured: 1 day
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)
Success rate of dogs trained in detecting COVID-19 from sweat samples taken from participating patients.
The status of patients (infected and uninfected with COVID-19 from the result of the PCR) will be compared to the result of the canine olfactory detection of COVID-19 in sweat samples.
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 posted26 Mar 2021
- Study start1 Mar 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
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
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Devillier, PhD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817371
- Sponsor's protocol ID
- 2021_0013
- Acronym
- VOCSARSCOVDep
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for SARS-CoV-2 Infection.
- ClinicalTrials.gov ID
- NCT04817371
- Acronym / sponsor ID
- VOCSARSCOVDep / 2021_0013
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 26 Mar 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.
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
- 4
| Arm | Type | Receives |
|---|---|---|
| Symptomatic patients with positive PCR | Other | Device: Volatile Organic Compounds analysis (e-noses), Other: Canine odor detection of Volatile Organic Compounds, Device: Volatile Organic Compounds analysis (mass spectrometry), Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)Patients with symptoms of COVID-19 and whose PCR result is positive |
| Symptomatic patients with positive PCR for other respiratory virus | Other | Device: Volatile Organic Compounds analysis (e-noses), Other: Canine odor detection of Volatile Organic Compounds, Device: Volatile Organic Compounds analysis (mass spectrometry), Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)Patients with symptomatic respiratory disease of infectious origin with negative RT-PCR for SARS-CoV-2 and positive RT-PCR for other respiratory viruses |
| Asymptomatic patients or healthy volunteers | Other | Device: Volatile Organic Compounds analysis (e-noses), Other: Canine odor detection of Volatile Organic Compounds, Device: Volatile Organic Compounds analysis (mass spectrometry), Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)Patients or healthy volunteers with negative RT-PCR and negative serology |
| Volunteers or patients vaccinated against COVID-19 | Other | Device: Volatile Organic Compounds analysis (e-noses), Other: Canine odor detection of Volatile Organic Compounds, Device: Volatile Organic Compounds analysis (mass spectrometry), Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject included in the Foch Hospital :
- Patients managed at the Foch Hospital with RT-PCR screening for SARS-CoV-2 infection
- Healthy volunteers among the hospital staff, asymptomatic, for whom an RT-PCR SARS-CoV-2 is indicated or recommended.
- Healthy hospital volunteers vaccinated against COVID (full vaccination schedule completed)
- At least 18 years of age;
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 analysis (e-noses)VOC analysis in exhaled air with e-noses. | Device | Asymptomatic patients or healthy volunteers, Symptomatic patients with positive PCR, Symptomatic patients with positive PCR for other respiratory virus, Volunteers or patients vaccinated against COVID-19 |
| Canine odor detection of Volatile Organic CompoundsVOC analysis in sweat by trained dogs. | Other | Asymptomatic patients or healthy volunteers, Symptomatic patients with positive PCR, Symptomatic patients with positive PCR for other respiratory virus, Volunteers or patients vaccinated against COVID-19 |
| Volatile Organic Compounds analysis (mass spectrometry)VOC analysis in exhaled air with mass spectrometry. | Device | Asymptomatic patients or healthy volunteers, Symptomatic patients with positive PCR, Symptomatic patients with positive PCR for other respiratory virus, Volunteers or patients vaccinated against COVID-19 |
| Volatile Organic Compounds analysis in sweat (mass spectrometry)VOC analysis in sweat with mass spectrometry. | Device | Asymptomatic patients or healthy volunteers, Symptomatic patients with positive PCR, Symptomatic patients with positive PCR for other respiratory virus, Volunteers or patients vaccinated against COVID-19 |
Primary outcome
The first co-objective of this experimental study is to determine if VOCs analyzed by electronic noses are of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
Time frame: 1 day
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by electronic noses) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID-19 and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
The second co-objective of this experimental study is to determine if VOCs analyzed by mass spectrometry is of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
Time frame: 1 day
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by mass spectrometry) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Philippe Devillier, PhD 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 (e-noses), Canine odor detection of Volatile Organic Compounds and Volatile Organic Compounds analysis (mass spectrometry) 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 8 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: status not confirmed, as of the sponsor's last update on 3 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Devillier, PhD (0146252791 ext. +33, p.devillier@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first co-objective of this experimental study is to determine if VOCs analyzed by electronic noses are of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection. (time frame: 1 day). The study lists 2 primary outcomes in all. 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 3 Aug 2022.