Covid19COVID-19NCT04602871
Early Detection of COVID-19 Using Breath Analysis - Feasibility Study
A study testing Breath Biopsy in people with Covid19, run by Scentech Medical Technologies Ltd at 2 sites in Israel.
Trial summary
Early Detection of COVID-19 Using Breath Analysis -Feasibility Study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Breath Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesIsrael
- Study dates
- 3 Jul 2020to 30 Jan 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospitalized group:
- Age 18 to 75 years at the time of consent
- Positive results for SARS-CoV-2
- Capable of understanding written and/or spoken language
- Able to provide informed consent
- Was not treated with Anti-viral drugs
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- Not a pregnant woman
- Healthy group:
- Healthy volunteers
- Age 18 to 75 years at the time of consent
- No history of COVID-19
- Capable of understanding written and/or spoken language
- Able to provide informed consent
- Was not treated with Anti-viral drugs
- Not a pregnant woman
- Sexes Eligible for Study: All
Who cannot join
- Hospitalized group:
- Age under 18 years old
- (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure or claustrophobia when wearing the sampling mask
- Persons under guardianship or deprived of liberty
- Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
- Healthy group:
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- Age under 18 years old
- History of COVID-19
- Persons under guardianship or deprived of liberty
- Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study
Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.
Read the detailed description
An interventional diagnostic prospective study study with risks and minimal constraints.
- Conditions
- Covid19
- Being tested
- Breath Biopsy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath BiopsyDiagnostic test
Breath Biopsy sampling using the ReCIVA® Breath Sampler
| Study group | Role | What they receive |
|---|---|---|
| COVID 19 Positive patients | Experimental | Patients with COVID-19, qPCR for SARS-CoV-2 confirmed Receives: Diagnostic Test: Breath Biopsy |
| Healthy subjects | Other | COVID-19 Negative subjects Receives: Diagnostic Test: Breath Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.
Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.
Measured: Through the study completion, up to 3 months.
Secondary outcomes (1)
Correlation between Volatile Organic Compounds pattern and the course of the disease
Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection intensity in a swab test.
Measured: Through the study completion, up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start3 Jul 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scentech Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Shitrit, MD, Principal investigator, Meir Medical Center, Kfar Saba, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602871
- Sponsor's protocol ID
- Cov-2-2020
- Acronym
- COVID-19
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPDs are to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study
- ClinicalTrials.gov ID
- NCT04602871
- Acronym / sponsor ID
- COVID-19 / Cov-2-2020
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Scentech Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 26 Oct 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.
Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.
Detailed description
An interventional diagnostic prospective study study with risks and minimal constraints.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID 19 Positive patients | Experimental | Diagnostic Test: Breath BiopsyPatients with COVID-19, qPCR for SARS-CoV-2 confirmed |
| Healthy subjects | Other | Diagnostic Test: Breath BiopsyCOVID-19 Negative subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18 to 75 years at the time of consent
- Positive results for SARS-CoV-2
- Capable of understanding written and/or spoken language
- Able to provide informed consent
- Was not treated with Anti-viral drugs
Key exclusion criteria (10 listed)
- Age under 18 years old
- (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure or claustrophobia when wearing the sampling mask
- Persons under guardianship or deprived of liberty
- Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
- Age under 18 years old
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 |
|---|---|---|
| Breath BiopsyBreath Biopsy sampling using the ReCIVA® Breath Sampler | Diagnostic test | COVID 19 Positive patients, Healthy subjects |
Primary outcome
Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.
Time frame: Through the study completion, up to 3 months.
Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.
1 secondary outcome
Correlation between Volatile Organic Compounds pattern and the course of the disease
Time frame: Through the study completion, up to 3 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 10 May 2022.
- Individual participant dataSharing planned: No. No IPDs are to be shared with other researchers.
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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.
David Shitrit, MD principal investigator
Meir Medical Center, Kfar Saba, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Biopsy in people with Covid19, run by Scentech Medical Technologies Ltd at 2 sites in Israel.
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 16 inclusion and 10 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection. (time frame: Through the study completion, up to 3 months.). 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 10 May 2022.