Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 Infection
- Conditions
- Covid19
- Interventions
- Device: Volatile Organic Compounds analysisOther: 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
-
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.
- Pregnant woman
- Patient deprived of liberty by judicial or administrative decision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Symptomatic patients with positive PCR Volatile Organic Compounds analysis Patients with symptoms of COVID-19 and whose PCR result is positive Asymptomatic patients or Healthy volunteers Canine odor detection of Volatile Organic Compounds 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 Symptomatic patients with positive PCR Canine odor detection of Volatile Organic Compounds Patients with symptoms of COVID-19 and whose PCR result is positive Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks Volatile Organic Compounds analysis 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 Symptomatic patients with negative PCR but with seroconversion within 4 to 8 weeks Canine odor detection of Volatile Organic Compounds 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 Asymptomatic patients or Healthy volunteers Volatile Organic Compounds analysis 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
- Primary Outcome Measures
Name Time Method Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection 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 Outcome Measures
Name Time Method 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 sweat 1 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