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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Foch
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Pregnant woman
- •Patient deprived of liberty by judicial or administrative decision
Arms & Interventions
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
Intervention: Volatile Organic Compounds analysis (Device)
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
Intervention: Canine odor detection of Volatile Organic Compounds (Other)
Symptomatic patients with positive PCR
Patients with symptoms of COVID-19 and whose PCR result is positive
Intervention: Volatile Organic Compounds analysis (Device)
Symptomatic patients with positive PCR
Patients with symptoms of COVID-19 and whose PCR result is positive
Intervention: Canine odor detection of Volatile Organic Compounds (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
Intervention: Volatile Organic Compounds analysis (Device)
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
Intervention: Canine odor detection of Volatile Organic Compounds (Other)
Outcomes
Primary Outcomes
Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection
Time Frame: 1 day
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
Secondary Outcomes
- Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)(1 day)
- Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat(1 day)