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

NCT04614883 | Completed

• 1 other identifier: 2020_0143
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat

  1 day

• Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)

  1 day

Study Arms (3)

Asymptomatic patients or Healthy volunteers

OTHER

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

Device: Volatile Organic Compounds analysis; Other: Canine odor detection of Volatile Organic Compounds

Symptomatic patients with positive PCR

OTHER

Patients with symptoms of COVID-19 and whose PCR result is positive

Device: Volatile Organic Compounds analysis; Other: Canine odor detection of Volatile Organic Compounds

Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks

OTHER

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

Device: Volatile Organic Compounds analysis; Other: Canine odor detection of Volatile Organic Compounds

Interventions

Volatile Organic Compounds analysis DEVICE

VOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry.

Asymptomatic patients or Healthy volunteers; Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks; Symptomatic patients with positive PCR

Canine odor detection of Volatile Organic Compounds OTHER

VOC analysis in sweat by trained dogs.

Asymptomatic patients or Healthy volunteers; Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks; Symptomatic patients with positive PCR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Foch hospital

Suresnes, 92151, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Helene Salvator, MD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 4, 2020
• Study Start: October 21, 2020
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)