Covid19COVIDNCT04508556
Performance Assessment of SARS-CoV-2 Detection Breath Biopsy - SARS-CoV-2 Study
An observational study of Covid19, run by Owlstone Ltd at 1 site in Netherlands.
Trial summary
The primary aim of this study is to investigate the performance of Breath Biopsy RD for the detection of SARS-CoV-2 in both a clinical and at home setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Breath Biopsy face masks with removable filters and fitted PVA strip, Nasopharyngeal swab and oropharyngeal swabs
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Sep 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 18 years and older
- All sexes
- 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
- Any adult >18 years with either a confirmed (phase 1) or suspected (phase 2\&3) SARS-CoV-2 infection will be eligible to participate in this study.
Who cannot join
- Subject who are deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds
- Subject who require non-invasive ventilation or high flow nasal oxygen
- Subject who require inotropic medication to maintain adequate organ perfusion
- Subject who have a communication barrier and / or unable to comply with the instructions to use the Breath Biopsy test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Assessment of SARS-CoV-2 Detection Through Analysis of Exhaled Breath Aerosols
The primary aim of this study is to investigate the performance of Breath Biopsy RD for the detection of SARS-CoV-2 in both a clinical and at home setting.
Read the detailed description
This study aims to evaluate Owlstone Medical's Breath Biopsy RD Collectors for the detection of SARS-CoV-2 infection. These single use disposable breath capture devices can be used independently by individuals and shipped to be analysed in a central lab for the presence of SARS-CoV-2 using established existing PCR assays available in any reference lab. The aerosol collectors furthermore directly sample exhaled breath aerosols. As such they directly sample the primary transmission route for the virus. This could result in a higher rate of retrieval of viral RNA in infected individuals thereby increasing the sensitivity of the applied PCR assay. This is underpinned by the fact that CT abnormalities in the lower airways appear to occur prior to upper respiratory tract samples becoming positive in cases suffering from nCOVID19, suggesting lower airway viral loads could be higher. Combined, this could enable more widespread access to diagnostics, reduce the need for repeat testing, decrease the need for healthcare professionals to perform diagnostic tests and reduce cross-contamination risk.
- Conditions
- Covid19
- Being tested
- Breath Biopsy face masks with removable filters and fitted PVA strip, Nasopharyngeal swab, oropharyngeal swabs
- 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 face masks with removable filters and fitted PVA stripDevice
Device developed for collection of breath samples
Nasopharyngeal swabDiagnostic test
Is a method for collecting a clinical test sample of nasal secretions from the back of the nose and throat.
oropharyngeal swabsDiagnostic test
Is a method for collecting a clinical test sample from the back of the throat.
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive control for technical validation
The purpose of this stage is to confirm the optimal extraction protocol to detect the presence of SARS-CoV-2 from the aerosols captured in the Breath Biopsy RD device. Up to two Breath Biopsy RD sample will be collected alongside a nasopharyngeal. The swab obtained during this stage is to be analysed in parallel to the extracted breath aerosols in the lab of the lab and will be used as a positive control.
Measured: 1 year
Secondary outcomes (1)
Evaluation of test performance
The aim is to assess the test performance of the Breath Biopsy RD devices in a real live clinical setting. Subjects with a high clinical suspicion of nCOVID-19 based on clinical triage will be requested to participate. A single Breath Biopsy RD collector will be collected in parallel with the standard diagnostic work-up consisting of a CT-scan and a nasopharyngeal swab.
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 posted11 Aug 2020
- Study start30 Sep 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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlstone Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OLVG, Maastricht University
- Responsible party
- Sponsor
- Investigators
- Paul Savelkoul,, Study chair, OLVGPaul Bresser, Study chair, Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508556
- Sponsor's protocol ID
- SARS-CoV-2 study
- Acronym
- COVID
- Status last verified
- Sep 2020
- First submitted
- 7 Aug 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of SARS-CoV-2 Detection Through Analysis of Exhaled Breath Aerosols
- ClinicalTrials.gov ID
- NCT04508556
- Acronym / sponsor ID
- COVID / SARS-CoV-2 study
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Owlstone LtdIndustry (pharma, biotech, devices)
- Collaborators
- OLVG, Maastricht University
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 11 Aug 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.
The primary aim of this study is to investigate the performance of Breath Biopsy RD for the detection of SARS-CoV-2 in both a clinical and at home setting.
Detailed description
This study aims to evaluate Owlstone Medical's Breath Biopsy RD Collectors for the detection of SARS-CoV-2 infection. These single use disposable breath capture devices can be used independently by individuals and shipped to be analysed in a central lab for the presence of SARS-CoV-2 using established existing PCR assays available in any reference lab. The aerosol collectors furthermore directly sample exhaled breath aerosols. As such they directly sample the primary transmission route for the virus. This could result in a higher rate of retrieval of viral RNA in infected individuals thereby increasing the sensitivity of the applied PCR assay. This is underpinned by the fact that CT abnormalities in the lower airways appear to occur prior to upper respiratory tract samples becoming positive in cases suffering from nCOVID19, suggesting lower airway viral loads could be higher. Combined, this could enable more widespread access to diagnostics, reduce the need for repeat testing, decrease the need for healthcare professionals to perform diagnostic tests and reduce cross-contamination risk.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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 (1 listed)
- Any adult >18 years with either a confirmed (phase 1) or suspected (phase 2\&3) SARS-CoV-2 infection will be eligible to participate in this study.
Key exclusion criteria (4 listed)
- Subject who are deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds
- Subject who require non-invasive ventilation or high flow nasal oxygen
- Subject who require inotropic medication to maintain adequate organ perfusion
- Subject who have a communication barrier and / or unable to comply with the instructions to use the Breath Biopsy test
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 | – |
| Nasopharyngeal swabIs a method for collecting a clinical test sample of nasal secretions from the back of the nose and throat. | Diagnostic test | – |
| oropharyngeal swabsIs a method for collecting a clinical test sample from the back of the throat. | Diagnostic test | – |
Primary outcome
Positive control for technical validation
Time frame: 1 year
The purpose of this stage is to confirm the optimal extraction protocol to detect the presence of SARS-CoV-2 from the aerosols captured in the Breath Biopsy RD device. Up to two Breath Biopsy RD sample will be collected alongside a nasopharyngeal. The swab obtained during this stage is to be analysed in parallel to the extracted breath aerosols in the lab of the lab and will be used as a positive control.
1 secondary outcome
Evaluation of test performance
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 1 Apr 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.
Paul Savelkoul, study chair
OLVG
Paul Bresser study chair
Maastricht
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 Covid19, run by Owlstone Ltd at 1 site in Netherlands.
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 1 inclusion and 4 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 1 Apr 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 Netherlands. 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?
Positive control for technical validation (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 1 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.