SARS-CoV-2 InfectionBREATHNCT04867213
Breath Analysis of Patients Diagnosed With COVID-19 Using Infrared Spectroscopy
An observational study of SARS-CoV-2 Infection and Covid19, run by McMaster University at 1 site in Canada.
Trial summary
To analyze Volatile Organic Compounds (VOCs) in the breath of patients with SARS-CoV-2 and controls in SARS-CoV-2 breath specimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, Covid19
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2021to 31 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients
Who may be able to join
- Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) with a positive result
- Clinical features in keeping with COVID-19 illness.
- Negative RT-PCR COVID-19 test
- Without any clinical features to suggest COVID-19 illness.
- No known or current features of respiratory infection, COPD, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer.
- Able to provide a breath sample (as based on clinical judgement).
- Exclusion Criteria for Covid-19 positive and negative patients:
- Unable to provide a breath sample
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 0A4
Mylinh Duong, MD, 905 525-9140, duongmy@mcmaster.ca
Mylinh Duong, MD
About this study
To analyze Volatile Organic Compounds (VOCs) in the breath of patients with SARS-CoV-2 and controls in SARS-CoV-2 breath specimens.
Read the detailed description
The study is a prospective cohort study, which enrol patients presenting to hospital and are tested for SARS-CoV-2. There will be two cohorts, COVID-19 positive and COVID-19 negative, who will have exhaled breath collection and analysis by infrared spectroscopy to characterize the composition of VOCs and identify differences in VOC profiles between the two groups.
- Conditions
- SARS-CoV-2 Infection, Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Positive | Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) and with a positive result and clinical features in keeping with COVID-19 illness. The investigators aim to collect breath samples within 7 days of symptom onset in 50% of Covid positive patients, with the remaining patients breath samples collected after 7 days of symptoms onset. | |
| SARS-CoV-2 Negative | Patients with a negative RT-PCR COVID-19 test and without any clinical features to suggest COVID-19 illness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath VOCs in covid positive and negative patients.
To examine Volatile Organic Compounds (VOCs) by infrared spectroscopy in the breath of patients with SARS-CoV-2 and controls to determine if VOCs within a breath sample can differentiate Covid-19 positive from Covid-19 negative patients.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Effect of time of symptom onset on VOCs in Covid-19 positive patients
To examine the effect of time of symptom onset on VOCs in the breath of Covid-19 positive patients. The investigators aim to collect breath samples within 7 days of symptom onset in 50% of Covid positive patients, with the remaining patients breath samples collected after 7 days of symptoms onset.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start15 Feb 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Breathe BioMedical Inc
- Responsible party
- Principal investigator, MyLinh Duong, McMaster University
- Investigators
- Mylinh Duong, MD, Principal investigator, McMaster University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867213
- Sponsor's protocol ID
- 12815
- Acronym
- BREATH
- Status last verified
- Apr 2021
- First submitted
- 24 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cusack RP, Larracy R, Morrell CB, Ranjbar M, Le Roux J, Whetstone CE, Boudreau M, Poitras PF, Srinathan T, Cheng E, Howie K, Obminski C, O'Shea T, Kruisselbrink RJ, Ho T, Scheme E, Graham S, Beydaghyan G, Gavreau GM, Duong M. Machine learning enabled detection of COVID-19 pneumonia using exhaled breath analysis: a proof-of-concept study. J Breath Res. 2024 Mar 13;18(2). doi: 10.1088/1752-7163/ad2b6e.
PubMed 38382095
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Analysis of Patients Diagnosed With COVID-19 Using Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT04867213
- Acronym / sponsor ID
- BREATH / 12815
- Conditions
- SARS-CoV-2 Infection, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Breathe BioMedical Inc
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 30 Apr 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.
To analyze Volatile Organic Compounds (VOCs) in the breath of patients with SARS-CoV-2 and controls in SARS-CoV-2 breath specimens.
Detailed description
The study is a prospective cohort study, which enrol patients presenting to hospital and are tested for SARS-CoV-2. There will be two cohorts, COVID-19 positive and COVID-19 negative, who will have exhaled breath collection and analysis by infrared spectroscopy to characterize the composition of VOCs and identify differences in VOC profiles between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Positive | – | –Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) and with a positive result and clinical features in keeping with COVID-19 illness. The investigators aim to collect breath samples within 7 days of symptom onset in 50% of Covid positive patients, with the remaining patients breath samples collected after 7 days of symptoms onset. |
| SARS-CoV-2 Negative | – | –Patients with a negative RT-PCR COVID-19 test and without any clinical features to suggest COVID-19 illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients
Key inclusion criteria (8 listed)
- Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) with a positive result
- Clinical features in keeping with COVID-19 illness.
- Negative RT-PCR COVID-19 test
- Without any clinical features to suggest COVID-19 illness.
- No known or current features of respiratory infection, COPD, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breath VOCs in covid positive and negative patients.
Time frame: Through study completion, an average of 1 year
To examine Volatile Organic Compounds (VOCs) by infrared spectroscopy in the breath of patients with SARS-CoV-2 and controls to determine if VOCs within a breath sample can differentiate Covid-19 positive from Covid-19 negative patients.
1 secondary outcome
Effect of time of symptom onset on VOCs in Covid-19 positive patients
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 38382095Cusack RP, Larracy R, Morrell CB, Ranjbar M, Le Roux J, Whetstone CE, Boudreau M, Poitras PF, Srinathan T, Cheng E, Howie K, Obminski C, O'Shea T, Kruisselbrink RJ, Ho T, Scheme E, Graham S, Beydaghyan G, Gavreau GM, Duong M. Machine learning enabled detection of COVID-19 pneumonia using exhaled breath analysis: a proof-of-concept study. J Breath Res. 2024 Mar 13;18(2). doi: 10.1088/1752-7163/ad2b6e.
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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.
Mylinh Duong, MD principal investigator
McMaster University Hospital
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 SARS-CoV-2 Infection and Covid19, run by McMaster University at 1 site in Canada.
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 0 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 30 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 Canada. 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 Gail Gauvreau, PhD (9055259140 ext. 22791, gauvreau@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath VOCs in covid positive and negative patients. (time frame: Through study completion, an average of 1 year). 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 NCT04867213, which also lists 1 linked publication.
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 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.