Clinical trial NCT04614883: Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 Infection
Official title: Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in Patients Referred to the Emergency Reception Service for Suspected COVID-19 Infection: Diagnostic Value and for Rapid Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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:

1. Patients

   * Patents anaged at the Foch Hospital for suspected COVID-19 and any other patient whose management requires diagnosis of SARS-CoV-2 infection
   * Patients aged 18 or over;
   * Patients Fluent in French ;
   * Patients with a signed consent form;
   * Patients with a health insurance plan.
2. Healthy volunteers

   * Foch Hospital staff asymptomatic for SARS-CoV-2 infection;
   * Aged 18 yor over;
   * Fluent in french;
   * with a signed consent form;
   * With a health insurance plan.

Exclusion Criteria:

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

Primary outcomes:
measure: Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a 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: Helene Salvator, MD
role: PRINCIPAL_INVESTIGATOR
References: