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

Hopital Foch

Status: Enrolling

Conditions: Covid19

Treatments: Other: Canine odor detection of Volatile Organic Compounds; Device: Volatile Organic Compounds analysis (e-noses); Device: Volatile Organic Compounds analysis (mass spectrometry); Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)

Study type: Interventional

Funder types: Other

Identifiers

NCT04817371

2021_0013

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 4 patient groups

Symptomatic patients with positive PCR

Other group

Description:

Patients with symptoms of COVID-19 and whose PCR result is positive

Treatment:

Device: Volatile Organic Compounds analysis (mass spectrometry)

Device: Volatile Organic Compounds analysis (e-noses)

Other: Canine odor detection of Volatile Organic Compounds

Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)

Symptomatic patients with positive PCR for other respiratory virus

Other group

Description:

Patients with symptomatic respiratory disease of infectious origin with negative RT-PCR for SARS-CoV-2 and positive RT-PCR for other respiratory viruses

Treatment:

Device: Volatile Organic Compounds analysis (mass spectrometry)

Device: Volatile Organic Compounds analysis (e-noses)

Other: Canine odor detection of Volatile Organic Compounds

Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)

Asymptomatic patients or healthy volunteers

Other group

Description:

Patients or healthy volunteers with negative RT-PCR and negative serology

Treatment:

Device: Volatile Organic Compounds analysis (mass spectrometry)

Device: Volatile Organic Compounds analysis (e-noses)

Other: Canine odor detection of Volatile Organic Compounds

Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)

Volunteers or patients vaccinated against COVID-19

Other group

Description:

Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)

Treatment:

Device: Volatile Organic Compounds analysis (mass spectrometry)

Device: Volatile Organic Compounds analysis (e-noses)

Other: Canine odor detection of Volatile Organic Compounds

Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)