COVID-19NCT05094674
Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.
A study testing Breath Sample analysis in people with COVID-19, run by Tera Group at 1 site in United Kingdom.
Trial summary
The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Breath Sample analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Oct 2021to 30 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Requiring a diagnostic or screening RT-PCR test for COVID-19
Who cannot join
- Subjects under general anaesthesia
- The inability to personally sign the consent form.
- The inability to exhale breath
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Tameside and Glossop Integrated Care NHS
Ashton-under-Lyne, Lancashire, OL6 9RW
Rebecca Roberts, 0161 922 4451, rebecca.roberts@tgh.nhs.uk
About this study
Official title: Clinical Validation of Biosafety Technologies Breath Analyser Tests for the Diagnosis of COVID-19; the Project Aims to Validate the Diagnostic Device and to Assess the Comparative Performance With RT-PCR Currently Being Deployed in the NHS.
The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19).
Read the detailed description
Within this proposed project, the NHS will collect two diagnostic or screening tests per participant. One sample will be used by NHS and be run through regular diagnostics. The second, will be breath sample which will be tested using the BioSafety Technologies Ltd, rapid screening tool. This will use a pre-defined protocol. These tests would then be compared to assess the diagnostic efficacy including sensitivity and specificities. We will be aiming to achieve a significant comparison to ensure certainty and to exploit the information for proposing a novel diagnostic system to enhance capabilities to scale up the testing of patients. The proposed activity involves clinical validation of BioSafety Testing, to enhance the performance of detection along with clinicians.
- Conditions
- COVID-19
- Being tested
- Breath Sample 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 Sample analysisDiagnostic test
The participant's breath sample is taken by blowing preferably three times into a disposable tube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis. This will take place once during the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants who require a diagnostic or screening COVID-19 RT-PCR test | Other | Participants who require a diagnostic or screening COVID-19 RT-PCR test, presenting at Tameside and Glossop Integrated Care NHS Foundation Trust aged 18 years or over Receives: Diagnostic Test: Breath Sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive and negative cases in collected breath samples using breath analyser test.
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 posted26 Oct 2021
- Study start22 Oct 2021
- Primary completion22 Jun 2022 (estimated)
- Study completion30 Jul 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
- Not applicable
- 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
- Investigators
- Ilan Lieberman, MD, Principal investigator, Tameside and Glossop Integrated Care NHS England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094674
- Sponsor's protocol ID
- BREATHE
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Biosafety Technologies Breath Analyser Tests for the Diagnosis of COVID-19; the Project Aims to Validate the Diagnostic Device and to Assess the Comparative Performance With RT-PCR Currently Being Deployed in the NHS.
- ClinicalTrials.gov ID
- NCT05094674
- Acronym / sponsor ID
- BREATHE
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tera GroupIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 22 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 26 Oct 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 is COVID-19-free (Negative to COVID-19).
Detailed description
Within this proposed project, the NHS will collect two diagnostic or screening tests per participant. One sample will be used by NHS and be run through regular diagnostics. The second, will be breath sample which will be tested using the BioSafety Technologies Ltd, rapid screening tool. This will use a pre-defined protocol. These tests would then be compared to assess the diagnostic efficacy including sensitivity and specificities. We will be aiming to achieve a significant comparison to ensure certainty and to exploit the information for proposing a novel diagnostic system to enhance capabilities to scale up the testing of patients. The proposed activity involves clinical validation of BioSafety Testing, to enhance the performance of detection along with clinicians.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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 |
|---|---|---|
| Participants who require a diagnostic or screening COVID-19 RT-PCR test | Other | Diagnostic Test: Breath Sample analysisParticipants who require a diagnostic or screening COVID-19 RT-PCR test, presenting at Tameside and Glossop Integrated Care NHS Foundation Trust aged 18 years or over |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Requiring a diagnostic or screening RT-PCR test for COVID-19
Key exclusion criteria (3 listed)
- Subjects under general anaesthesia
- The inability to personally sign the consent form.
- The inability to exhale breath
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 Sample analysisThe participant's breath sample is taken by blowing preferably three times into a disposable tube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis. This will take place once during the study. | Diagnostic test | Participants who require a diagnostic or screening COVID-19 RT-PCR test |
Primary outcome
Rate of positive and negative cases in collected breath samples using breath analyser test.
Time frame: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Ilan Lieberman, MD principal investigator
Tameside and Glossop Integrated Care NHS England
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 Sample analysis in people with COVID-19, run by Tera Group at 1 site in United Kingdom.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Roberts (0161 922 4451, rebecca.roberts@tgh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of positive and negative cases in collected breath samples using breath analyser test. (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 26 Oct 2021.