Covid-19 InfectionNCT04459962
Covid-19 Breath Test
A study testing Breath Test & Cheek Swab in people with Covid-19 Infection, run by Ancon Technologies Ltd at 1 site in United Kingdom.
Trial summary
Can Nanotechnology Biomarker Tagging (NBT) be used to detect COVID-19 infection in people presenting for COVID-19 testing? NBT can be used to detect the substances present in a person's breath. In this study the breath of people presenting for COVID-19 testing is going to be analysed. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19 Infection
- What is being tested?
- Breath Test & Cheek Swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jun 2020to 7 Jan 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male \& Females.
- Age Above 16 years old
- All Ethnicity
- Any patients that come for COVID-19 testing
- COVID Negative Patients (Further participants may be selected as control groups who have no current diagnosis of COVID-19.)
- COVID Positive In-Patients
Who cannot join
- Outside of stated age range - below 16
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ashford and St Peter's Hospitals NHS Foundation Trust
Chertsey, Surrey, KT16 0PZ
About this study
Official title: Breath Test Feasibility Trial for Covid-19 Infection Diagnosis
Can Nanotechnology Biomarker Tagging (NBT) be used to detect COVID-19 infection in people presenting for COVID-19 testing?
NBT can be used to detect the substances present in a person's breath. In this study the breath of people presenting for COVID-19 testing is going to be analysed. Analysing a large number of samples from people with COVID-19 (as confirmed by the standard swab test used by the NHS) will enable a breath profile to be produced, ie the substances present in the breath when someone has COVID-19. After the profile has been validated, NBT can be used to test whether or not a person has COVID-19 by seeing if their breath matches the profile.
Using this technology for COVID-19 testing has advantages over the current standard test. The sample can be analysed immediately in the clinical setting and the results are available in 5-10 minutes, so if the person tests negative they can go back to their normal life straight away. The current swab test takes around 72 hours for the results to be available, and the person needs to self-isolate during this time in case they test positive, resulting in potentially unnecessary days of work missed and inconvenience. The breath test is non-invasive and is unlikely to cause any discomfort, as the person is only required to breath normally into the device. This study will also review the practicalities of using this test. It is quick and easy to train people in how to carry out the test, so it could potentially easily be rolled out to testing sites.
Read the detailed description
This is a Cohort Study which will collect non-invasive, expired breath sample, cheek swab and a Medical and Lifestyle questionnaire from participants.
When the participant presents for COVID-19 testing they will be asked to provide a cheek swab and breath sample, and complete the study questionnaire. They will not need to give any identifiable information or have a second visit. The samples will be analysed immediately and disposed of as clinical waste. ANCON will then use the data to build a breath profile of COVID-19 infection.
Sample and data collection method for inpatients:
- Sequential (daily or every other day as able) breath and swab test will be taken from some of the patients admitted in the hospital (inpatients).
- This will be taken from entry or start of the study to discharge or end of study or until patient or medical staff deem unsuitable to continue
- This will enable to track infection and the relevant profile changes as covid-19 progresses and/or is treated. This will provide vital additional information around identifiers associated with the disease and its progress.
Anonymous Questionnaire - Each participant will be asked questions in the form of a short standard questionnaire based on:
- Medical Information
- Lifestyle Information
- Conditions
- Covid-19 Infection
- Being tested
- Breath Test & Cheek Swab
- 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 Test & Cheek SwabDiagnostic test
Breath Sample and Cheek Swab of participants will be used for machine learning (NBT - Nanobiotechnology Biomarkers Tagging) system to develop a profile which can be used later on for Covid-19 Diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Breath Test and Cheek Swab collection Receives: Diagnostic Test: Breath Test & Cheek Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms
This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample. These will be combined to provide a COVID-19 positive profile
Measured: 6 Months
Secondary outcomes (2)
-To profile the unique pattern of Volatile Organic Compounds (VOCs) found in the expired breath of COVID-19 patients using the NBT system (VOC analysis and ML).
This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample using ML. These will be combined to provide a COVID-19 positive profile.
Measured: 6 months
To differentiate this unique profile from the patients that are found to be negative for COVID-19
The patient samples that return COVID-19 negative will be used as controls for identification of VOCs and relative concentrations that are common to all samples.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start29 Jun 2020
- Primary completion7 Jan 2021
- Study completion7 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Covid-19 InfectionStudies 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
- Participants who are Covid-19 negative, Covid-19 positive or suspected with Covid-19 infection will be recruited
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ancon Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Winchester, MBBS, MSc, Principal investigator, Ashford and St Peter's Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459962
- Sponsor's protocol ID
- 2020ATL01
- Status last verified
- Jul 2020
- First submitted
- 3 Jul 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ajibola OA, Smith D, Spanel P, Ferns GA. Effects of dietary nutrients on volatile breath metabolites. J Nutr Sci. 2013 Oct 31;2:e34. doi: 10.1017/jns.2013.26. eCollection 2013.
PubMed 25191584Smith D, Spanel P. The challenge of breath analysis for clinical diagnosis and therapeutic monitoring. Analyst. 2007 May;132(5):390-6. doi: 10.1039/b700542n. Epub 2007 Mar 19.
PubMed 17471381Amann A, Spanel P, Smith D. Breath analysis: the approach towards clinical applications. Mini Rev Med Chem. 2007 Feb;7(2):115-29. doi: 10.2174/138955707779802606.
PubMed 17305586Gouma PI, Wang L, Simon SR, Stanacevic M. Novel Isoprene Sensor for a Flu Virus Breath Monitor. Sensors (Basel). 2017 Jan 20;17(1):199. doi: 10.3390/s17010199.
PubMed 28117692Kim, K.-H.Kim., Jahan, S.A., Kabir, E., (2012) A review of breath analysis for diagnosis of human health. TrAC Trends in Analytical Chemistry. v.33, 1-8. https://doi.org/10.1016/j.trac.2011.09.013
Lake MA. What we know so far: COVID-19 current clinical knowledge and research. Clin Med (Lond). 2020 Mar;20(2):124-127. doi: 10.7861/clinmed.2019-coron. Epub 2020 Mar 5.
PubMed 32139372Marczin N, Kharitonov S (2003) Lung Biology in Health and Disease. Disease Markers in Exhaled Breath Edited by: New York: Marcel Dekker; 2003.
NHS-England, (2020) Guidance and standard operating procedure COVID-19 virus testing in NHS laboratories.
Sethi S, Nanda R, Chakraborty T. Clinical application of volatile organic compound analysis for detecting infectious diseases. Clin Microbiol Rev. 2013 Jul;26(3):462-75. doi: 10.1128/CMR.00020-13.
PubMed 23824368Risby T., (2005): Current status of clinical breath analysis. In Breath Analysis for Clinical Diagnosis and Therapeutic Monitoring Edited by: Amann A, Smith D. Singapore: World Scientific; 2005:251-265.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Test Feasibility Trial for Covid-19 Infection Diagnosis
- ClinicalTrials.gov ID
- NCT04459962
- Acronym / sponsor ID
- 2020ATL01
- Conditions
- Covid-19 Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Ancon Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 7 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.
Can Nanotechnology Biomarker Tagging (NBT) be used to detect COVID-19 infection in people presenting for COVID-19 testing?
NBT can be used to detect the substances present in a person's breath. In this study the breath of people presenting for COVID-19 testing is going to be analysed. Analysing a large number of samples from people with COVID-19 (as confirmed by the standard swab test used by the NHS) will enable a breath profile to be produced, ie the substances present in the breath when someone has COVID-19. After the profile has been validated, NBT can be used to test whether or not a person has COVID-19 by seeing if their breath matches the profile.
Using this technology for COVID-19 testing has advantages over the current standard test. The sample can be analysed immediately in the clinical setting and the results are available in 5-10 minutes, so if the person tests negative they can go back to their normal life straight away. The current swab test takes around 72 hours for the results to be available, and the person needs to self-isolate during this time in case they test positive, resulting in potentially unnecessary days of work missed and inconvenience. The breath test is non-invasive and is unlikely to cause any discomfort, as the person is only required to breath normally into the device. This study will also review the practicalities of using this test. It is quick and easy to train people in how to carry out the test, so it could potentially easily be rolled out to testing sites.
Detailed description
This is a Cohort Study which will collect non-invasive, expired breath sample, cheek swab and a Medical and Lifestyle questionnaire from participants.
When the participant presents for COVID-19 testing they will be asked to provide a cheek swab and breath sample, and complete the study questionnaire. They will not need to give any identifiable information or have a second visit. The samples will be analysed immediately and disposed of as clinical waste. ANCON will then use the data to build a breath profile of COVID-19 infection.
Sample and data collection method for inpatients:
- Sequential (daily or every other day as able) breath and swab test will be taken from some of the patients admitted in the hospital (inpatients).
- This will be taken from entry or start of the study to discharge or end of study or until patient or medical staff deem unsuitable to continue
- This will enable to track infection and the relevant profile changes as covid-19 progresses and/or is treated. This will provide vital additional information around identifiers associated with the disease and its progress.
Anonymous Questionnaire - Each participant will be asked questions in the form of a short standard questionnaire based on:
- Medical Information
- Lifestyle Information
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants who are Covid-19 negative, Covid-19 positive or suspected with Covid-19 infection will be recruited
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Diagnostic Test: Breath Test & Cheek SwabBreath Test and Cheek Swab collection |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male \& Females.
- Age Above 16 years old
- All Ethnicity
- Any patients that come for COVID-19 testing
- COVID Negative Patients (Further participants may be selected as control groups who have no current diagnosis of COVID-19.)
Key exclusion criteria (2 listed)
- Outside of stated age range - below 16
- Unable to consent
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 Test & Cheek SwabBreath Sample and Cheek Swab of participants will be used for machine learning (NBT - Nanobiotechnology Biomarkers Tagging) system to develop a profile which can be used later on for Covid-19 Diagnosis. | Diagnostic test | Study Arm |
Primary outcome
To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms
Time frame: 6 Months
This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample. These will be combined to provide a COVID-19 positive profile
2 secondary outcomes
-To profile the unique pattern of Volatile Organic Compounds (VOCs) found in the expired breath of COVID-19 patients using the NBT system (VOC analysis and ML).
Time frame: 6 months
To differentiate this unique profile from the patients that are found to be negative for COVID-19
Time frame: 6 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 29 Jan 2021.
- Background: PubMed 25191584Ajibola OA, Smith D, Spanel P, Ferns GA. Effects of dietary nutrients on volatile breath metabolites. J Nutr Sci. 2013 Oct 31;2:e34. doi: 10.1017/jns.2013.26. eCollection 2013.
- Background: PubMed 17471381Smith D, Spanel P. The challenge of breath analysis for clinical diagnosis and therapeutic monitoring. Analyst. 2007 May;132(5):390-6. doi: 10.1039/b700542n. Epub 2007 Mar 19.
- Background: PubMed 17305586Amann A, Spanel P, Smith D. Breath analysis: the approach towards clinical applications. Mini Rev Med Chem. 2007 Feb;7(2):115-29. doi: 10.2174/138955707779802606.
- Background: PubMed 28117692Gouma PI, Wang L, Simon SR, Stanacevic M. Novel Isoprene Sensor for a Flu Virus Breath Monitor. Sensors (Basel). 2017 Jan 20;17(1):199. doi: 10.3390/s17010199.
- BackgroundKim, K.-H.Kim., Jahan, S.A., Kabir, E., (2012) A review of breath analysis for diagnosis of human health. TrAC Trends in Analytical Chemistry. v.33, 1-8. https://doi.org/10.1016/j.trac.2011.09.013
- Background: PubMed 32139372Lake MA. What we know so far: COVID-19 current clinical knowledge and research. Clin Med (Lond). 2020 Mar;20(2):124-127. doi: 10.7861/clinmed.2019-coron. Epub 2020 Mar 5.
- BackgroundMarczin N, Kharitonov S (2003) Lung Biology in Health and Disease. Disease Markers in Exhaled Breath Edited by: New York: Marcel Dekker; 2003.
- BackgroundNHS-England, (2020) Guidance and standard operating procedure COVID-19 virus testing in NHS laboratories.
- Background: PubMed 23824368Sethi S, Nanda R, Chakraborty T. Clinical application of volatile organic compound analysis for detecting infectious diseases. Clin Microbiol Rev. 2013 Jul;26(3):462-75. doi: 10.1128/CMR.00020-13.
- BackgroundRisby T., (2005): Current status of clinical breath analysis. In Breath Analysis for Clinical Diagnosis and Therapeutic Monitoring Edited by: Amann A, Smith D. Singapore: World Scientific; 2005:251-265.
- 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.
Stephen Winchester, MBBS, MSc principal investigator
Ashford and St Peter's Hospitals NHS Foundation Trust
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 Test & Cheek Swab in people with Covid-19 Infection, run by Ancon Technologies 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 6 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: finished, as of the sponsor's last update on 29 Jan 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?
To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04459962, which also lists 10 linked publications.
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 29 Jan 2021.