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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Device: Volatile Organic Compounds analysis (e-noses); Other: Canine odor detection of Volatile Organic Compounds; Device: Volatile Organic Compounds analysis (mass spectrometry); Device: Volatile Organic Compounds analysis in sweat (mass spectrometry)

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Hulier-Ammar, PhD; Phone Number: 0146251175; Email: drci-promotion@hopital-foch.com

Study Locations

• France
  • Suresnes, France, 92151
    • Recruiting
    • Foch hospital
    • Contact: Hélène Salvator, MD; Phone Number: 0146252955; Email: h.salvator@hopital-foch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Symptomatic patients with positive PCR; Patients with symptoms of COVID-19 and whose PCR result is positive	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.; Device: Volatile Organic Compounds analysis in sweat (mass spectrometry); VOC analysis in sweat with mass spectrometry.
Other: 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	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.; Device: Volatile Organic Compounds analysis in sweat (mass spectrometry); VOC analysis in sweat with mass spectrometry.
Other: Asymptomatic patients or healthy volunteers; Patients or healthy volunteers with negative RT-PCR and negative serology	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.; Device: Volatile Organic Compounds analysis in sweat (mass spectrometry); VOC analysis in sweat with mass spectrometry.
Other: Volunteers or patients vaccinated against COVID-19; Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)	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.; Device: Volatile Organic Compounds analysis in sweat (mass spectrometry); VOC analysis in sweat with mass spectrometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021_0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No