Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for COVID-19 Infection. (VOCSARSCOVDep)
Primary Purpose
Covid19
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Volatile Organic Compounds analysis (e-noses)
Canine odor detection of Volatile Organic Compounds
Volatile Organic Compounds analysis (mass spectrometry)
Volatile Organic Compounds analysis in sweat (mass spectrometry)
Sponsored by
About this trial
This is an interventional other trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Subject included in the Foch Hospital :
- Patients managed at the Foch Hospital with RT-PCR screening for SARS-CoV-2 infection
- Healthy volunteers among the hospital staff, asymptomatic, for whom an RT-PCR SARS-CoV-2 is indicated or recommended.
- Healthy hospital volunteers vaccinated against COVID (full vaccination schedule completed)
- At least 18 years of age;
- Fluency in the French language;
- Have signed a consent form;
- Be affiliated with a health insurance plan.
Exclusion Criteria:
- Pregnant woman
- Patient deprived of liberty by judicial or administrative decision
Sites / Locations
- Foch hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Symptomatic patients with positive PCR
Symptomatic patients with positive PCR for other respiratory virus
Asymptomatic patients or healthy volunteers
Volunteers or patients vaccinated against COVID-19
Arm Description
Patients with symptoms of COVID-19 and whose PCR result is positive
Patients with symptomatic respiratory disease of infectious origin with negative RT-PCR for SARS-CoV-2 and positive RT-PCR for other respiratory viruses
Patients or healthy volunteers with negative RT-PCR and negative serology
Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)
Outcomes
Primary Outcome Measures
The first co-objective of this experimental study is to determine if VOCs analyzed by electronic noses are of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by electronic noses) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID-19 and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
The second co-objective of this experimental study is to determine if VOCs analyzed by mass spectrometry is of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by mass spectrometry) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
Secondary Outcome Measures
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 identified by mass spectrometry.
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)
Success rate of dogs trained in detecting COVID-19 from sweat samples taken from participating patients.
The status of patients (infected and uninfected with COVID-19 from the result of the PCR) will be compared to the result of the canine olfactory detection of COVID-19 in sweat samples.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04817371
Brief Title
Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for COVID-19 Infection.
Acronym
VOCSARSCOVDep
Official Title
Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for SARS-CoV-2 Infection.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Symptomatic patients with positive PCR
Arm Type
Other
Arm Description
Patients with symptoms of COVID-19 and whose PCR result is positive
Arm Title
Symptomatic patients with positive PCR for other respiratory virus
Arm Type
Other
Arm Description
Patients with symptomatic respiratory disease of infectious origin with negative RT-PCR for SARS-CoV-2 and positive RT-PCR for other respiratory viruses
Arm Title
Asymptomatic patients or healthy volunteers
Arm Type
Other
Arm Description
Patients or healthy volunteers with negative RT-PCR and negative serology
Arm Title
Volunteers or patients vaccinated against COVID-19
Arm Type
Other
Arm Description
Volunteers or patients vaccinated against COVID-19 (complete vaccination scheme)
Intervention Type
Device
Intervention Name(s)
Volatile Organic Compounds analysis (e-noses)
Intervention Description
VOC analysis in exhaled air with e-noses.
Intervention Type
Other
Intervention Name(s)
Canine odor detection of Volatile Organic Compounds
Intervention Description
VOC analysis in sweat by trained dogs.
Intervention Type
Device
Intervention Name(s)
Volatile Organic Compounds analysis (mass spectrometry)
Intervention Description
VOC analysis in exhaled air with mass spectrometry.
Intervention Type
Device
Intervention Name(s)
Volatile Organic Compounds analysis in sweat (mass spectrometry)
Intervention Description
VOC analysis in sweat with mass spectrometry.
Primary Outcome Measure Information:
Title
The first co-objective of this experimental study is to determine if VOCs analyzed by electronic noses are of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
Description
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by electronic noses) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID-19 and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
Time Frame
1 day
Title
The second co-objective of this experimental study is to determine if VOCs analyzed by mass spectrometry is of interest for the diagnosis of an infection by SARS-CoV-2 (COVID-19) infection.
Description
Identification of VOC profiles specific to the SARS-CoV-2 (VOC analysis by mass spectrometry) on exhalates collected under resting breathing conditions between patients with symptoms suggestive of COVID and SARS-CoV-2 infection confirmed by RT-PCR, those whose infection is ruled out on the basis of the negativity RT-PCR and clinical/radiological data (non-COVID control patients), and those with another symptomatic respiratory viral infection confirmed by positive PCR for viruses other than SARS-CoV-2 other than SARS-CoV-2.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat
Description
The equivalences and differences in nature of VOCs associated with infection with SARS-CoV-2 between exhaled air and sweat identified by mass spectrometry.
Time Frame
1 day
Title
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)
Description
Success rate of dogs trained in detecting COVID-19 from sweat samples taken from participating patients.
The status of patients (infected and uninfected with COVID-19 from the result of the PCR) will be compared to the result of the canine olfactory detection of COVID-19 in sweat samples.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject included in the Foch Hospital :
Patients managed at the Foch Hospital with RT-PCR screening for SARS-CoV-2 infection
Healthy volunteers among the hospital staff, asymptomatic, for whom an RT-PCR SARS-CoV-2 is indicated or recommended.
Healthy hospital volunteers vaccinated against COVID (full vaccination schedule completed)
At least 18 years of age;
Fluency in the French language;
Have signed a consent form;
Be affiliated with a health insurance plan.
Exclusion Criteria:
Pregnant woman
Patient deprived of liberty by judicial or administrative decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Devillier, PhD
Phone
0146252791
Ext
+33
Email
p.devillier@hopital-foch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Hulier-Ammar, PhD
Phone
0146251175
Email
drci-promotion@hopital-foch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Devillier, PhD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foch hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Devillier, PhD
Phone
0146252791
Email
p.devillier@hopital-foch.com
First Name & Middle Initial & Last Name & Degree
Hélène Salvator, MD
Phone
0146252955
Email
h.salvator@hopital-foch.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for COVID-19 Infection.
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