Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for COVID-19 Infection.

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for SARS-CoV-2 Infection.

Conditions
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Covid19

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Pregnant woman Patient deprived of liberty by judicial or administrative decision

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Symptomatic patients with positive PCR<br>Patients with symptoms of COVID-19 and whose PCR result is positive | Device: Volatile Organic Compounds analysis (e-noses)<br>* VOC analysis in exhaled air with e-noses.<br>Other: Canine odor detection of Volatile Organic Compounds<br>* VOC analysis in sweat by trained dogs.<br>Device: Volatile Organic Compounds analysis (mass spectrometry)<br>* VOC analysis in exhaled air with mass spectrometry.<br>Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)<br>* VOC analysis in sweat with mass spectrometry.<br>|
| Other: Symptomatic patients with positive PCR for other respiratory virus<br>Patients with symptomatic respiratory disease of infectious origin with negative RT-PCR for SARS-CoV-2 and positive RT-PCR for other respiratory viruses | Device: Volatile Organic Compounds analysis (e-noses)<br>* VOC analysis in exhaled air with e-noses.<br>Other: Canine odor detection of Volatile Organic Compounds<br>* VOC analysis in sweat by trained dogs.<br>Device: Volatile Organic Compounds analysis (mass spectrometry)<br>* VOC analysis in exhaled air with mass spectrometry.<br>Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)<br>* VOC analysis in sweat with mass spectrometry.<br>|
| Other: Asymptomatic patients or healthy volunteers<br>Patients or healthy volunteers with negative RT-PCR and negative serology | Device: Volatile Organic Compounds analysis (e-noses)<br>* VOC analysis in exhaled air with e-noses.<br>Other: Canine odor detection of Volatile Organic Compounds<br>* VOC analysis in sweat by trained dogs.<br>Device: Volatile Organic Compounds analysis (mass spectrometry)<br>* VOC analysis in exhaled air with mass spectrometry.<br>Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)<br>* VOC analysis in sweat with mass spectrometry.<br>|
| Other: Volunteers or patients vaccinated against COVID-19<br>Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme) | Device: Volatile Organic Compounds analysis (e-noses)<br>* VOC analysis in exhaled air with e-noses.<br>Other: Canine odor detection of Volatile Organic Compounds<br>* VOC analysis in sweat by trained dogs.<br>Device: Volatile Organic Compounds analysis (mass spectrometry)<br>* VOC analysis in exhaled air with mass spectrometry.<br>Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)<br>* VOC analysis in sweat with mass spectrometry.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 day |