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

Covid19 Clinical Trial

— VOCSARSCOVDep  

Official title:

Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for SARS-CoV-2 Infection.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04817371
• Other study ID #: 2021_0013
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 2022

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: Philippe Devillier, PhD
• Phone: 0146252791
• Email: p.devillier[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Device:
• Volatile Organic Compounds analysis (e-noses)
VOC analysis in exhaled air with e-noses.

Other:
• Canine odor detection of Volatile Organic Compounds
VOC analysis in sweat by trained dogs.

Device:
• Volatile Organic Compounds analysis (mass spectrometry)
VOC analysis in exhaled air with mass spectrometry.
• Volatile Organic Compounds analysis in sweat (mass spectrometry)
VOC analysis in sweat with mass spectrometry.

Locations

Country	Name	City	State
France	Foch hospital	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

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