COVID-19NCT05162495
Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.
A study testing BioStation T101 and TeraTube in people with COVID-19, run by Tera Group.
Trial summary
The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- BioStation T101 and TeraTube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Aug 2022
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General:
- Male or female subject aged 18 years and above
- Subject is able and willing to provide informed consent
- Subject is able to complete the breath test.
- Arm A:
- Requiring a diagnostic or screening RT-PCR test for COVID-19.
- Arm B:
- Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.
Who cannot join
- Male of female subject under the age of 18.
- Subject is unable to provide and informed consent, for any reason.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Center, Two Arms, Non-interventional, Breath Samples Collection Clinical Trial, for Development of the TERA Bio Station T101, Intended for SARS-CoV-2 Exhalation Products Detection.
The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.
Read the detailed description
According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples.
The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements.
Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.
The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.
- Conditions
- COVID-19
- Being tested
- BioStation T101 and TeraTube
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioStation T101 and TeraTubeDevice
Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Requiring a diagnostic or screening RT-PCR test for COVID-19. Receives: Device: BioStation T101 and TeraTube |
| Arm B | Experimental | Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening. Receives: Device: BioStation T101 and TeraTube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results.
Measured: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The participant's breath sample is taken by blowing preferably three times into a disposable TeraTube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis of its bio-chemical spectral signature. This will take place once during the study.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tera Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162495
- Sponsor's protocol ID
- TERA-COV-02
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 11 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Two Arms, Non-interventional, Breath Samples Collection Clinical Trial, for Development of the TERA Bio Station T101, Intended for SARS-CoV-2 Exhalation Products Detection.
- ClinicalTrials.gov ID
- NCT05162495
- Acronym / sponsor ID
- TERA-COV-02
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tera GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 17 Dec 2021 (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 Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.
Detailed description
According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples.
The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements.
Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.
The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participant's breath sample is taken by blowing preferably three times into a disposable TeraTube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis of its bio-chemical spectral signature. This will take place once during the study.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Device: BioStation T101 and TeraTubeRequiring a diagnostic or screening RT-PCR test for COVID-19. |
| Arm B | Experimental | Device: BioStation T101 and TeraTubePositive to COVID-19 in RT-PCR test performed up to 48 hours before screening. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subject aged 18 years and above
- Subject is able and willing to provide informed consent
- Subject is able to complete the breath test.
- Requiring a diagnostic or screening RT-PCR test for COVID-19.
- Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.
Key exclusion criteria (2 listed)
- Male of female subject under the age of 18.
- Subject is unable to provide and informed consent, for any reason.
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 |
|---|---|---|
| BioStation T101 and TeraTubeRapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples. | Device | Arm A, Arm B |
Primary outcome
Primary Outcome Measure
Time frame: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample
Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Questions about this trial
What is this clinical trial studying?
A study testing BioStation T101 and TeraTube in people with COVID-19, run by Tera Group.
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 8 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yebgeny Marzon, MD (+972 50 764 3281, emarzon@leumit.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample). 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 11 Jan 2022.