Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 Infection (VOC-COVID-Diag)

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

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: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Canine odor detection of Volatile Organic Compounds; Device: Volatile Organic Compounds analysis

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92151
    • FOCH Hospital

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Asymptomatic patients or Healthy volunteers; Patient with no symptom of COVID-19 infection but for whom a PCR test needs to be done because he has been in contact with a COVID-19 positive person	Other: Canine odor detection of Volatile Organic Compounds; VOC analysis in sweat by trained dogs.; Device: Volatile Organic Compounds analysis; VOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry.
OTHER: Symptomatic patients with positive PCR; Patients with symptoms of COVID-19 and whose PCR result is positive	Other: Canine odor detection of Volatile Organic Compounds; VOC analysis in sweat by trained dogs.; Device: Volatile Organic Compounds analysis; VOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry.
OTHER: Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks; Patients with symptoms of COVID-19 and whose PCR result is negative at inclusion but presents a seroconversion within 4 to 8 weeks post inclusion	Other: Canine odor detection of Volatile Organic Compounds; VOC analysis in sweat by trained dogs.; Device: Volatile Organic Compounds analysis; VOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection	Comparison of variation of Volatile Organic Compound (VOC) profiles in exhaled air of patients between patients with symptoms suggestive of COVID and infection confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and those whose infection is ruled out based on the negativity of RT-PCR and clinical data	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.	1 day
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)	Proportion of success in detecting samples from patients with symptoms suggestive of COVID and infection confirmed by PCR.	1 day

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Helene Salvator, MD, Hopital Foch

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 21, 2020
• Primary Completion (ACTUAL): February 26, 2021
• Study Completion (ACTUAL): February 26, 2021

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (ACTUAL): November 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

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: 2020_0143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No