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

NCT ID: NCT04817371

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-09-30

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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Symptomatic patients with positive PCR

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

Group Type OTHER

Volatile Organic Compounds analysis (e-noses)

Intervention Type DEVICE

VOC analysis in exhaled air with e-noses.

Canine odor detection of Volatile Organic Compounds

Intervention Type OTHER

VOC analysis in sweat by trained dogs.

Volatile Organic Compounds analysis (mass spectrometry)

Intervention Type DEVICE

VOC analysis in exhaled air with mass spectrometry.

Volatile Organic Compounds analysis in sweat (mass spectrometry)

Intervention Type DEVICE

VOC analysis in sweat with mass spectrometry.

Symptomatic patients with positive PCR for other respiratory virus

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

Group Type OTHER

Volatile Organic Compounds analysis (e-noses)

Intervention Type DEVICE

VOC analysis in exhaled air with e-noses.

Canine odor detection of Volatile Organic Compounds

Intervention Type OTHER

VOC analysis in sweat by trained dogs.

Volatile Organic Compounds analysis (mass spectrometry)

Intervention Type DEVICE

VOC analysis in exhaled air with mass spectrometry.

Volatile Organic Compounds analysis in sweat (mass spectrometry)

Intervention Type DEVICE

VOC analysis in sweat with mass spectrometry.

Asymptomatic patients or healthy volunteers

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

Group Type OTHER

Volatile Organic Compounds analysis (e-noses)

Intervention Type DEVICE

VOC analysis in exhaled air with e-noses.

Canine odor detection of Volatile Organic Compounds

Intervention Type OTHER

VOC analysis in sweat by trained dogs.

Volatile Organic Compounds analysis (mass spectrometry)

Intervention Type DEVICE

VOC analysis in exhaled air with mass spectrometry.

Volatile Organic Compounds analysis in sweat (mass spectrometry)

Intervention Type DEVICE

VOC analysis in sweat with mass spectrometry.

Volunteers or patients vaccinated against COVID-19

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

Group Type OTHER

Volatile Organic Compounds analysis (e-noses)

Intervention Type DEVICE

VOC analysis in exhaled air with e-noses.

Canine odor detection of Volatile Organic Compounds

Intervention Type OTHER

VOC analysis in sweat by trained dogs.

Volatile Organic Compounds analysis (mass spectrometry)

Intervention Type DEVICE

VOC analysis in exhaled air with mass spectrometry.

Volatile Organic Compounds analysis in sweat (mass spectrometry)

Intervention Type DEVICE

VOC analysis in sweat with mass spectrometry.

Interventions

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Volatile Organic Compounds analysis (e-noses)

VOC analysis in exhaled air with e-noses.

Intervention Type DEVICE

Canine odor detection of Volatile Organic Compounds

VOC analysis in sweat by trained dogs.

Intervention Type OTHER

Volatile Organic Compounds analysis (mass spectrometry)

VOC analysis in exhaled air with mass spectrometry.

Intervention Type DEVICE

Volatile Organic Compounds analysis in sweat (mass spectrometry)

VOC analysis in sweat with mass spectrometry.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Devillier, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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Foch hospital

Suresnes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe Devillier, PhD

Role: CONTACT

0146252791 ext. +33

Elisabeth Hulier-Ammar, PhD

Role: CONTACT

0146251175

Facility Contacts

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Philippe Devillier, PhD

Role: primary

0146252791

Hélène Salvator, MD

Role: backup

0146252955

Other Identifiers

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2021_0013

Identifier Type: -

Identifier Source: org_study_id

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