Back to resultsAnalysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by SARS-COV-2 (COVID-19) (VOC-COVID)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Volatile Organic Compounds analysis
Sponsored by
About this trial
This is an interventional other trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Patients infected by SARS-CoV-2 whose medical condition warrants hospitalisation (out of intensive care) for oxygen therapy less or equal to 4 l/min
- Patients must be 18 years of age or older
- Fluent in the French language
- Have signed a consent form
- Being affiliated with healthcare insurance
Exclusion Criteria:
- Pregnant woman
- Patient deprived of liberty by judicial or administrative decision
Sites / Locations
- Hôpital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Volatile Organic Compounds analysis
Arm Description
Volatile Organic Compounds analysis in exhaled air in patients hospitalised for COVID-19 infection
Outcomes
Primary Outcome Measures
Profiles of volatile organic compounds (VOCs) in exhaled air between 2 health conditions
Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled). The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between patients who improve and patients who get worse during their hospitalisation for COVID-19 infection
Secondary Outcome Measures
Profiles of volatile organic compounds (VOCs) in exhaled air on 1 health condition
Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the start and the discharge to the hospital in patients infecting and recovering from COVID-19.
Profiles of volatile organic compounds (VOCs) in exhaled air between 2 periods
Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the hospitalisation period and a post-hospitalisation follow-up consultation in patients infected by COVID-19 and recovered.
Profiles of volatile organic compounds (VOCs) in exhaled air by mass spectrometry at each visit based on patient evolution status.
Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from mass spectrometry, at hospitalisation, post-hospitalisation and follow-up consultation in patients infected by COVID-19 and recovered.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04379154
Brief Title
Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by SARS-COV-2 (COVID-19)
Acronym
VOC-COVID
Official Title
Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by (SARS-CoV-2): Predictive Interest in Short-term Evolution
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 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
The study of volatile organic compounds (VOCs) detected in exhaled air is an innovative research area for respiratory diseases. This analysis can be done by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOCs without identifying them. The VOCs in exhaled air in patients hospitalized for COVID-19 infection are analysed in this study, using electronic noses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volatile Organic Compounds analysis
Arm Type
Experimental
Arm Description
Volatile Organic Compounds analysis in exhaled air in patients hospitalised for COVID-19 infection
Intervention Type
Device
Intervention Name(s)
Volatile Organic Compounds analysis
Intervention Description
Volatile Organic Compounds analysis in exhaled air by electronic noses
Primary Outcome Measure Information:
Title
Profiles of volatile organic compounds (VOCs) in exhaled air between 2 health conditions
Description
Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled). The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between patients who improve and patients who get worse during their hospitalisation for COVID-19 infection
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Profiles of volatile organic compounds (VOCs) in exhaled air on 1 health condition
Description
Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the start and the discharge to the hospital in patients infecting and recovering from COVID-19.
Time Frame
2 weeks
Title
Profiles of volatile organic compounds (VOCs) in exhaled air between 2 periods
Description
Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the hospitalisation period and a post-hospitalisation follow-up consultation in patients infected by COVID-19 and recovered.
Time Frame
4 months
Title
Profiles of volatile organic compounds (VOCs) in exhaled air by mass spectrometry at each visit based on patient evolution status.
Description
Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from mass spectrometry, at hospitalisation, post-hospitalisation and follow-up consultation in patients infected by COVID-19 and recovered.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients infected by SARS-CoV-2 whose medical condition warrants hospitalisation (out of intensive care) for oxygen therapy less or equal to 4 l/min
Patients must be 18 years of age or older
Fluent in the French language
Have signed a consent form
Being affiliated with healthcare insurance
Exclusion Criteria:
Pregnant woman
Patient deprived of liberty by judicial or administrative decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Salvator
Organizational Affiliation
Pneumology unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by SARS-COV-2 (COVID-19)
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