Covid19COVID-19NCT04602949
Detection of COVID-19 Using Breath Analysis - Validation Study
A study testing Breath Biopsy Analysis in people with Covid19, run by Scentech Medical Technologies Ltd at 1 site in Israel.
Trial summary
DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Breath Biopsy Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,558 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Nov 2020to 18 Jan 2023
- 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 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 6 to 75 years at the time of consent
- Capable of understanding written and/or spoken language
- Able to provide informed consent
- Was not treated with Anti-viral drugs
Who cannot join
- Age under 6 years old
- Under guardianship or deprived of liberty
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study
DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
Read the detailed description
A diagnostic prospective single-site study, with no anticipated risks or constraints.
Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.
- Conditions
- Covid19
- Being tested
- Breath Biopsy 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.
Breath Biopsy AnalysisDiagnostic test
Analysis of a single breath Biopsy
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | Experimental | subjects who were found as COVID-19 positive patients by swab RT-PCR Receives: Diagnostic Test: Breath Biopsy Analysis |
| Healthy controls | Other | subjects who were found as COVID-19 Negative, by swab RT-PCR Receives: Diagnostic Test: Breath Biopsy Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Volatile Organic Compounds indicating carriers of COVID-19.
Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.
Measured: Through the study completion, up to 3 months.
Secondary outcomes (2)
Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.).
Correlation level between exhaled biomarkers and participants' demographic characteristics.
Measured: Through the study completion, up to 3 months.
sensitivity level of biomarkers' algorithm.
comparison of algorithm's sensitivity level to the sensitivity of COVID-19 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 start12 Nov 2020
- Primary completion28 May 2022
- Study completion18 Jan 2023
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
- 2,558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scentech Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Dror, PhD, Study director, Scentech Medical Technologies Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602949
- Sponsor's protocol ID
- Cov-2-SMC-2020
- Acronym
- COVID-19
- Status last verified
- Feb 2022
- First submitted
- 21 Oct 2020
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD is to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study
- ClinicalTrials.gov ID
- NCT04602949
- Acronym / sponsor ID
- COVID-19 / Cov-2-SMC-2020
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,558 participants (actual)
- Lead sponsor
- Scentech Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 18 Jan 2023 (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.
DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
Detailed description
A diagnostic prospective single-site study, with no anticipated risks or constraints.
Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.
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 patients | Experimental | Diagnostic Test: Breath Biopsy Analysissubjects who were found as COVID-19 positive patients by swab RT-PCR |
| Healthy controls | Other | Diagnostic Test: Breath Biopsy Analysissubjects who were found as COVID-19 Negative, by swab RT-PCR |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 6 to 75 years at the time of consent
- Capable of understanding written and/or spoken language
- Able to provide informed consent
- Was not treated with Anti-viral drugs
Key exclusion criteria (3 listed)
- Age under 6 years old
- Under guardianship or deprived of liberty
- Pregnant or lactating woman
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 Biopsy AnalysisAnalysis of a single breath Biopsy | Diagnostic test | COVID-19 patients, Healthy controls |
Primary outcome
Presence of Volatile Organic Compounds indicating carriers of COVID-19.
Time frame: Through the study completion, up to 3 months.
Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.
2 secondary outcomes
Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.).
Time frame: Through the study completion, up to 3 months.
sensitivity level of biomarkers' algorithm.
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 16 May 2023.
- Individual participant dataSharing planned: No. No IPD is 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.
Natalie Dror, PhD study director
Scentech Medical Technologies Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Biopsy Analysis in people with Covid19, run by Scentech Medical Technologies Ltd at 1 site 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 4 inclusion and 3 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 16 May 2023. 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 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?
Presence of Volatile Organic Compounds indicating carriers of COVID-19. (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 16 May 2023.