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

Not Applicable
Completed
Conditions
Covid19
Interventions
Device: Volatile Organic Compounds analysis
Other: Canine odor detection of Volatile Organic Compounds
Registration Number
NCT04614883
Lead Sponsor
Hopital Foch
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
130
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.
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Exclusion Criteria
  • Pregnant woman
  • Patient deprived of liberty by judicial or administrative decision
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Symptomatic patients with positive PCRVolatile Organic Compounds analysisPatients with symptoms of COVID-19 and whose PCR result is positive
Asymptomatic patients or Healthy volunteersCanine odor detection of Volatile Organic CompoundsPatient 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
Symptomatic patients with positive PCRCanine odor detection of Volatile Organic CompoundsPatients with symptoms of COVID-19 and whose PCR result is positive
Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeksVolatile Organic Compounds analysisPatients with symptoms of COVID-19 and whose PCR result is negative at inclusion but presents a seroconversion within 4 to 8 weeks post inclusion
Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeksCanine odor detection of Volatile Organic CompoundsPatients with symptoms of COVID-19 and whose PCR result is negative at inclusion but presents a seroconversion within 4 to 8 weeks post inclusion
Asymptomatic patients or Healthy volunteersVolatile Organic Compounds analysisPatient 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
Primary Outcome Measures
NameTimeMethod
Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection1 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 Outcome Measures
NameTimeMethod
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)1 day

Proportion of success in detecting samples from patients with symptoms suggestive of COVID and infection confirmed by PCR.

Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat1 day

The equivalences and differences in nature of VOCs associated with infection with SARS-CoV-2 between exhaled air and sweat.

Trial Locations

Locations (1)

Foch hospital

🇫🇷

Suresnes, France

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