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

Covid19 Clinical Trial

— VOC-COVID-Diag  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614883
• Other study ID #: 2020_0143
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: February 26, 2021

Study information

• Verified date: June 2021
• Source: Hopital Foch
• Contact: n/a
• 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: Completed
• Enrollment: 130
• Est. completion date: February 26, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

Device:
• Volatile Organic Compounds analysis
VOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry.

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

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	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	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
Secondary	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