- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379154
Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by SARS-COV-2 (COVID-19) (VOC-COVID)
January 12, 2022 updated by: Hopital Foch
Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by (SARS-CoV-2): Predictive Interest in Short-term Evolution
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Suresnes, France
- Hopital Foch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Volatile Organic Compounds analysis
Volatile Organic Compounds analysis in exhaled air in patients hospitalised for COVID-19 infection
|
Volatile Organic Compounds analysis in exhaled air by electronic noses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Profiles of volatile organic compounds (VOCs) in exhaled air between 2 health conditions
Time Frame: 1 day
|
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
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Profiles of volatile organic compounds (VOCs) in exhaled air on 1 health condition
Time Frame: 2 weeks
|
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.
|
2 weeks
|
|
Profiles of volatile organic compounds (VOCs) in exhaled air between 2 periods
Time Frame: 4 months
|
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.
|
4 months
|
|
Profiles of volatile organic compounds (VOCs) in exhaled air by mass spectrometry at each visit based on patient evolution status.
Time Frame: 4 months
|
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.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hélène Salvator, Pneumology Unit
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 14, 2020
Primary Completion (ACTUAL)
June 1, 2021
Study Completion (ACTUAL)
June 1, 2021
Study Registration Dates
First Submitted
April 28, 2020
First Submitted That Met QC Criteria
May 6, 2020
First Posted (ACTUAL)
May 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2022
Last Update Submitted That Met QC Criteria
January 12, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020_0060
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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