Clinical trial NCT04817371: Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for COVID-19 Infection.
Official title: Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for SARS-CoV-2 Infection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
Secondary outcomes:
measure: Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat
timeFrame: 1 day
measure: Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)
timeFrame: 1 day
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Foch hospital
Study officials:
affiliation: Hopital Foch
name: Philippe Devillier, PhD
role: PRINCIPAL_INVESTIGATOR
References: