COVIDNCT04467112
Non Inferiority Trial for Detection of nCOVID-19 Through Analysis of Exhaled Breath Aerosols
An observational study of COVID, run by Owlstone Ltd at 1 site in United Kingdom.
Trial summary
This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19. These are single use disposable breath capture devices with removable filters and fitted PVA strip that directly sample exhaled breath aerosols and therefore, directly… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID
- What is being tested?
- Breath Biopsy face masks with removable filters and fitted PVA strip
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2020to 19 Dec 2020
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The inclusion and exclusion criteria for the various study populations are detailed above. General inclusion and exclusion criteria which apply to all study subjects are detailed followed by indication specific criteria are also detailed for both inclusion and exclusion.
Who may be able to join
- Provide written informed consent
- Be 16 years or older
- Suspected or confirmed nCOVID-19 infection
Who cannot join
- Subjects unable to provide written informed consent
- Ineligible subjects will specifically include subjects:
- deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds Require non-invasive ventilation or high flow nasal oxygen
- who require inotropic medication to maintain adequate organ perfusion
- communication barrier and / or unable to comply with the instructions to use the Breath Biopsy face masks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospital NHS
Cambridge, CB2 0QQ
About this study
This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19.
These are single use disposable breath capture devices with removable filters and fitted PVA strip that directly sample exhaled breath aerosols and therefore, directly sample the primary transmission route for the virus. They can be used independently and shipped for analysis for the presence of nCOVID-19 using established existing assays available in any reference lab.
Read more
The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face mask vs. available diagnostic procedures in standard care and will also asses the feasibility of patient use of the equipment.
Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient characteristics (e.g. age, sex) are collected.
Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to obtain to address the primary study hypothesis. Due to the pre-test probability of patients being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a combination of imaging, viral diagnostics and clinical assessment will be used as the reference standard. When this number hits 100 the study will be discontinued. In total no more than 500 subjects shall be sampled in this trial.
Read the detailed description
Subjects will be recruited for the study during their scheduled appointments per clinical practice to the site, no separate study visit is required.
The participant's involvement in the study will be limited to one visit (per routine practice) only. No additional follow up is required.
For the purpose of the study a breath sample will be collected using the Breath Biopsy face masks. Collection of exhaled breath aerosols using these single use, disposable face masks will require subjects to breath normally into these face masks, the total collection time will not exceed one hour. It is expected to reduce collection times after initial validation steps to the shortest time providing sufficient diagnostic accuracy.
Given the non-invasive nature of these breath collections subjects can immediately provide up to two samples using the Breath Biopsy face masks. The breath collection should occur within 24 hours of the diagnostic sample.
Collected samples will be either frozen or shipped for rtPCR analysis of the presence of nCOVID-19 RNA. The two Breath Biopsy face masks can be used as technical replicates and/or to validate different storage conditions.
- Conditions
- COVID
- Being tested
- Breath Biopsy face masks with removable filters and fitted PVA strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath Biopsy face masks with removable filters and fitted PVA stripDevice
Device developed for collection of breath samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of nCOVID-19 using a face mask
The primary aim of this study is to establish non-inferiority of the Breath Biopsy face masks with various respiratory droplet (aerosol) capture techniques for the detection of nCOVID-19 compared to the current diagnostic test results per standard practice.
Measured: 1 year
Secondary outcomes (1)
Independent Patient use of face mask
The secondary objective is to assess the feasibility of independent use of the Breath Biopsy face masks. This will be measured by means of patient reported feedback on their level of comfort in performing the breath collection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start30 Jul 2020
- Primary completion19 Dec 2020
- Study completion19 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlstone Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Stefan Marciniak, Study chair, Cambridge Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467112
- Sponsor's protocol ID
- COVID-Breath
- Status last verified
- Mar 2021
- First submitted
- 30 Jun 2020
- Last updated
- 30 Mar 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 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Inferiority Trial for Detection of nCOVID-19 Through Analysis of Exhaled Breath Aerosols
- ClinicalTrials.gov ID
- NCT04467112
- Acronym / sponsor ID
- COVID-Breath
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Owlstone LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 10 Jul 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.
This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19.
These are single use disposable breath capture devices with removable filters and fitted PVA strip that directly sample exhaled breath aerosols and therefore, directly sample the primary transmission route for the virus. They can be used independently and shipped for analysis for the presence of nCOVID-19 using established existing assays available in any reference lab.
The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face mask vs. available diagnostic procedures in standard care and will also asses the feasibility of patient use of the equipment.
Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient characteristics (e.g. age, sex) are collected.
Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to obtain to address the primary study hypothesis. Due to the pre-test probability of patients being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a combination of imaging, viral diagnostics and clinical assessment will be used as the reference standard. When this number hits 100 the study will be discontinued. In total no more than 500 subjects shall be sampled in this trial.
Detailed description
Subjects will be recruited for the study during their scheduled appointments per clinical practice to the site, no separate study visit is required.
The participant's involvement in the study will be limited to one visit (per routine practice) only. No additional follow up is required.
For the purpose of the study a breath sample will be collected using the Breath Biopsy face masks. Collection of exhaled breath aerosols using these single use, disposable face masks will require subjects to breath normally into these face masks, the total collection time will not exceed one hour. It is expected to reduce collection times after initial validation steps to the shortest time providing sufficient diagnostic accuracy.
Given the non-invasive nature of these breath collections subjects can immediately provide up to two samples using the Breath Biopsy face masks. The breath collection should occur within 24 hours of the diagnostic sample.
Collected samples will be either frozen or shipped for rtPCR analysis of the presence of nCOVID-19 RNA. The two Breath Biopsy face masks can be used as technical replicates and/or to validate different storage conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The inclusion and exclusion criteria for the various study populations are detailed above. General inclusion and exclusion criteria which apply to all study subjects are detailed followed by indication specific criteria are also detailed for both inclusion and exclusion.
Key inclusion criteria (3 listed)
- Provide written informed consent
- Be 16 years or older
- Suspected or confirmed nCOVID-19 infection
Key exclusion criteria (5 listed)
- Subjects unable to provide written informed consent
- Ineligible subjects will specifically include subjects:
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 face masks with removable filters and fitted PVA stripDevice developed for collection of breath samples | Device | – |
Primary outcome
Detection of nCOVID-19 using a face mask
Time frame: 1 year
The primary aim of this study is to establish non-inferiority of the Breath Biopsy face masks with various respiratory droplet (aerosol) capture techniques for the detection of nCOVID-19 compared to the current diagnostic test results per standard practice.
1 secondary outcome
Independent Patient use of face mask
Time frame: 1 year
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 30 Mar 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.
Stefan Marciniak study chair
Cambridge Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Owlstone Ltd 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 5 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 30 Mar 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?
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?
Detection of nCOVID-19 using a face mask (time frame: 1 year). 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 30 Mar 2021.