COVID-19VOC-COVIDNCT04379154
Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by SARS-COV-2 (COVID-19)
A study testing Volatile Organic Compounds analysis in people with COVID-19, run by Hopital Foch at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Volatile Organic Compounds analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant woman
- Patient deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- Volatile Organic Compounds analysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volatile Organic Compounds analysisDevice
Volatile Organic Compounds analysis in exhaled air by electronic noses
| Study group | Role | What they receive |
|---|---|---|
| Volatile Organic Compounds analysis | Experimental | Volatile Organic Compounds analysis in exhaled air in patients hospitalised for COVID-19 infection Receives: Device: Volatile Organic Compounds analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 2 weeks
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start14 Apr 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Salvator, Principal investigator, Pneumology unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379154
- Sponsor's protocol ID
- 2020_0060
- Acronym
- VOC-COVID
- Status last verified
- Jan 2022
- First submitted
- 28 Apr 2020
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04379154
- Acronym / sponsor ID
- VOC-COVID / 2020_0060
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volatile Organic Compounds analysis | Experimental | Device: Volatile Organic Compounds analysisVolatile Organic Compounds analysis in exhaled air in patients hospitalised for COVID-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant woman
- Patient deprived of liberty by judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volatile Organic Compounds analysisVolatile Organic Compounds analysis in exhaled air by electronic noses | Device | Volatile Organic Compounds analysis |
Primary outcome
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
3 secondary outcomes
Profiles of volatile organic compounds (VOCs) in exhaled air on 1 health condition
Time frame: 2 weeks
Profiles of volatile organic compounds (VOCs) in exhaled air between 2 periods
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Salvator principal investigator
Pneumology unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volatile Organic Compounds analysis in people with COVID-19, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profiles of volatile organic compounds (VOCs) in exhaled air between 2 health conditions (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.