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

Not Applicable

• Conditions: Covid19
• Interventions: 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)

• Registration Number: NCT04817371
• Lead Sponsor: Hopital Foch

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

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.

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Exclusion Criteria

• Pregnant woman
• Patient deprived of liberty by judicial or administrative decision

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volunteers or patients vaccinated against COVID-19	Volatile Organic Compounds analysis (mass spectrometry)	Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)
Symptomatic patients with positive PCR for other respiratory virus	Canine odor detection of Volatile Organic Compounds	Patients with symptomatic respiratory disease of infectious origin with negative RT-PCR for SARS-CoV-2 and positive RT-PCR for other respiratory viruses
Symptomatic patients with positive PCR	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	Volatile Organic Compounds analysis (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	Volatile Organic Compounds analysis (e-noses)	Patients or healthy volunteers with negative RT-PCR and negative serology
Asymptomatic patients or healthy volunteers	Volatile Organic Compounds analysis (mass spectrometry)	Patients or healthy volunteers with negative RT-PCR and negative serology
Asymptomatic patients or healthy volunteers	Volatile Organic Compounds analysis in sweat (mass spectrometry)	Patients or healthy volunteers with negative RT-PCR and negative serology
Symptomatic patients with positive PCR	Canine odor detection of Volatile Organic Compounds	Patients with symptoms of COVID-19 and whose PCR result is positive
Asymptomatic patients or healthy volunteers	Canine odor detection of Volatile Organic Compounds	Patients or healthy volunteers with negative RT-PCR and negative serology
Volunteers or patients vaccinated against COVID-19	Volatile Organic Compounds analysis (e-noses)	Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)
Volunteers or patients vaccinated against COVID-19	Canine odor detection of Volatile Organic Compounds	Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)
Symptomatic patients with positive PCR	Volatile Organic Compounds analysis (e-noses)	Patients with symptoms of COVID-19 and whose PCR result is positive
Symptomatic patients with positive PCR	Volatile Organic Compounds analysis (mass spectrometry)	Patients with symptoms of COVID-19 and whose PCR result is positive
Volunteers or patients vaccinated against COVID-19	Volatile Organic Compounds analysis in sweat (mass spectrometry)	Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)
Symptomatic patients with positive PCR for other respiratory virus	Volatile Organic Compounds analysis (e-noses)	Patients with symptomatic respiratory disease of infectious origin with negative RT-PCR for SARS-CoV-2 and positive RT-PCR for other respiratory viruses
Symptomatic patients with positive PCR for other respiratory virus	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

Primary Outcome Measures

Name	Time	Method
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.	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.	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.

Secondary Outcome Measures

Name	Time	Method
Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat	1 day	The equivalences and differences in nature of VOCs associated with infection with SARS-CoV-2 between exhaled air and sweat identified by mass spectrometry.
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)	1 day	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.

Trial Locations

Locations (1)

Foch hospital; 🇫🇷 Suresnes, France