Covid19COVID-19NCT04602884
Early Detection of COVID-19 Using Breath Analysis
A study testing Breath biopsy sampling using the ReCIVA Breath Sampler in people with Covid19, run by Scentech Medical Technologies Ltd at 1 site in Israel.
Trial summary
EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Breath biopsy sampling using the ReCIVA Breath Sampler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Sep 2020to 30 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 55 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
Who cannot join
- 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
- Pregnant women
- Treated with antiviral drugs upon admission or during hospitalization
- Novices and soldiers in initial training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis: First Cross-Sectional Study
EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY
Read the detailed description
Primary objective- to identify and evaluate a set of biomarkers that represent both the genetic expression of the virus itself (SARS-CoV-2) and the metabolic activity of the immune system's response to the virus.
- Conditions
- Covid19
- Being tested
- Breath biopsy sampling using the ReCIVA Breath Sampler
- 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 sampling using the ReCIVA Breath SamplerDiagnostic test
Breath biopsy sampling using the ReCIVA Breath Sampler
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Positive patients | Experimental | subjects who were found COVID-19 Positive according to swab test. Receives: Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler |
| Healthy subjects | Other | subjects who were found COVID-19 Negative according to swab test. Receives: Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Volatile Organic Compounds pattern and COVID-19 detection status.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and COVID-19 detection presence in a swab test.
Measured: Through the study completion, up to 3 months.
Secondary outcomes (2)
Correlation between Volatile Organic Compounds pattern and time from COVID-19 detection.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and time since COVID-19 detected in a swab test.
Measured: Through the study completion, up to 3 months.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and intensity of COVID-19 detected 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 start22 Sep 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 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
- 50 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
- NCT04602884
- Sponsor's protocol ID
- Cov-2-IDF
- Acronym
- COVID-19
- Status last verified
- Feb 2022
- First submitted
- 21 Oct 2020
- Last updated
- 7 Feb 2022
- 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 7 Feb 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: First Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04602884
- Acronym / sponsor ID
- COVID-19 / Cov-2-IDF
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Scentech Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 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- FIRST CROSS-SECTIONAL STUDY
Detailed description
Primary objective- to identify and evaluate a set of biomarkers that represent both the genetic expression of the virus itself (SARS-CoV-2) and the metabolic activity of the immune system's response to the virus.
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 biopsy sampling using the ReCIVA Breath Samplersubjects who were found COVID-19 Positive according to swab test. |
| Healthy subjects | Other | Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Samplersubjects who were found COVID-19 Negative according to swab test. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 55 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
Key exclusion criteria (7 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
- Pregnant women
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 sampling using the ReCIVA Breath SamplerBreath biopsy sampling using the ReCIVA Breath Sampler | Diagnostic test | COVID-19 Positive patients, Healthy subjects |
Primary outcome
Correlation between Volatile Organic Compounds pattern and COVID-19 detection status.
Time frame: Through the study completion, up to 3 months.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and COVID-19 detection presence in a swab test.
2 secondary outcomes
Correlation between Volatile Organic Compounds pattern and time from COVID-19 detection.
Time frame: Through the study completion, up to 3 months.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity.
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 7 Feb 2022.
- 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 sampling using the ReCIVA Breath Sampler 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 7 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 7 Feb 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 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 and COVID-19 detection status. (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 7 Feb 2022.