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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Volatile Organic Compounds analysis
Canine odor detection of Volatile Organic Compounds
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

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

Sites / Locations

  • Foch hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Asymptomatic patients or Healthy volunteers

Symptomatic patients with positive PCR

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

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.
Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19)
Proportion of success in detecting samples from patients with symptoms suggestive of COVID and infection confirmed by PCR.

Full Information

First Posted
November 2, 2020
Last Updated
June 11, 2021
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT04614883
Brief Title
Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 Infection
Acronym
VOC-COVID-Diag
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
February 26, 2021 (Actual)

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
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asymptomatic patients or Healthy volunteers
Arm Type
Other
Arm Description
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
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 negative PCR but with seroconversion within 4 to 8 weeks
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Volatile Organic Compounds analysis
Intervention Description
VOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry.
Intervention Type
Other
Intervention Name(s)
Canine odor detection of Volatile Organic Compounds
Intervention Description
VOC analysis in sweat by trained dogs.
Primary Outcome Measure Information:
Title
Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection
Description
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
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.
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
Proportion of success in detecting samples from patients with symptoms suggestive of COVID and infection confirmed by PCR.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Pregnant woman Patient deprived of liberty by judicial or administrative decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Salvator, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foch hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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