COVID-19NCT06571136
The Measurement of Chemicals in Exhaled Breath Can Identify If a Person is Infected with COVID-19
An observational study of COVID-19, run by N5 Sensors at 1 site in United States.
Trial summary
The type and number of chemicals in exhaled breath are different in people with infection as compared to those without infection. In this study, the breath of people with and without COVID infection will be measured. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 26 Feb 2025
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who present at a regional emergency department
Who may be able to join
- Subject must complete the consent process
- Subjects of both sexes must be ≥ 18 and ≤ 70 years old
- Control subjects must have negative RT-PCR and antigen test
- COVID subjects must have a positive RT-PCR and/or antigen test.
Who cannot join
- Subjects with severe lung disease which would prevent them from providing a breath sample through a large bore tube (e.g., large drinking straw)
- Subjects with uncontrolled diabetes (e.g., ketoacidosis)
- Subjects who are routinely exposed to paints, paint thinners, gasoline, varnishes, glues, dry cleaning solvents, or industrial cleaning products
- Subjects who are daily smokers of cigarettes, e-cigarettes, tobacco products, or marijuana
- Subjects who have consumed alcohol in the previous 24 hours
- Have not consumed large amounts of garlic (38 grams) over the prior 24 hours. This amount of garlic can come from approximately 6 garlic cloves or garlic supplement capsules,
- Subjects who are experiencing respiratory failure
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Providence Regional Medical Center Everett
Everett, Washington, 98201
Rebecca Watson, BS, 425-261-3547, beccawatson@providence.org
George Diaz, MD
About this study
Official title: Identification of COVID-19 Infection from Measurement of Exhaled Breath
The type and number of chemicals in exhaled breath are different in people with infection as compared to those without infection. In this study, the breath of people with and without COVID infection will be measured. Changes in the amount and type of chemicals in breath will be used to determine if an individual does or does not have COVID infection. If the measurements of breath are a reliable measure of COVID infection, this device may be used to rapidly screen people who are attending large public events (for example, music concert or baseball game) to minimize the spread of COVID at the event.
Read the detailed description
N5 Sensors has developed a device that can measure chemical concentrations at parts-per-billion levels (for example, 10 molecules in one-billion molecules is 10 parts-per-billion). This device will be used to measure a variety of chemicals in the exhaled breath of human volunteers. The measured chemicals have been selected based on their presence in the breath of subjects with COVID infection. In addition to measuring breath, samples of mucus from the nose of these same subjects will be collected. These nasal samples will be evaluated to determine the presence of the COVID virus and of COVID infection. Changes in chemicals in the breath will be compared to the presence of COVID or to infection with COVID. This comparison will determine if measurement of breath can be used as a quick and simple measure of COVID infection.
- Conditions
- COVID-19
- Keywords
- Breath testing, COVID-19, Nasal swab
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled chemicals in breath will be compared with COVID status
Between subjects with and without COVID, changes in the chemical composition of exhaled breath are correlated with markers of COVID infection: 1) antigen testing of nasal mucous sample and 2) RT-PCR testing of nasal mucous sample.
Measured: On the day of enrollment, all measurement will be made over the course of 2 hours.
Measurement of chemical composition in exhaled breath
Each subject will provide two breath samples. Each sample will be analyzed by the RISE device.
Measured: On the day of enrollment, all measurement will be made over the course of 2 hours.
Assessment of COVID status using nasal swab.
Two nasal swabs will be collected for each subject. One nasal swab will be evaluated by antigen testing and the other sample will be analyzed using RT-PCR.
Measured: On the day of enrollment, all measurement will be made over the course of 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start19 Aug 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion26 Feb 2025 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N5 Sensors
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Providence Health & Services, U.S. Department of Homeland Security
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571136
- Sponsor's protocol ID
- N5-202401
- Other IDs
- 70RSAT22C00000019
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of COVID-19 Infection from Measurement of Exhaled Breath
- ClinicalTrials.gov ID
- NCT06571136
- Acronym / sponsor ID
- N5-202401
- Conditions
- COVID-19
- Keywords
- Breath testing, COVID-19, Nasal swab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- N5 SensorsIndustry (pharma, biotech, devices)
- Collaborators
- Providence Health & Services, U.S. Department of Homeland Security
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 26 Feb 2025 (estimated)
- First posted
- 26 Aug 2024 (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 type and number of chemicals in exhaled breath are different in people with infection as compared to those without infection. In this study, the breath of people with and without COVID infection will be measured. Changes in the amount and type of chemicals in breath will be used to determine if an individual does or does not have COVID infection. If the measurements of breath are a reliable measure of COVID infection, this device may be used to rapidly screen people who are attending large public events (for example, music concert or baseball game) to minimize the spread of COVID at the event.
Detailed description
N5 Sensors has developed a device that can measure chemical concentrations at parts-per-billion levels (for example, 10 molecules in one-billion molecules is 10 parts-per-billion). This device will be used to measure a variety of chemicals in the exhaled breath of human volunteers. The measured chemicals have been selected based on their presence in the breath of subjects with COVID infection. In addition to measuring breath, samples of mucus from the nose of these same subjects will be collected. These nasal samples will be evaluated to determine the presence of the COVID virus and of COVID infection. Changes in chemicals in the breath will be compared to the presence of COVID or to infection with COVID. This comparison will determine if measurement of breath can be used as a quick and simple measure of COVID infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who present at a regional emergency department
Key inclusion criteria (4 listed)
- Subject must complete the consent process
- Subjects of both sexes must be ≥ 18 and ≤ 70 years old
- Control subjects must have negative RT-PCR and antigen test
- COVID subjects must have a positive RT-PCR and/or antigen test.
Key exclusion criteria (7 listed)
- Subjects with severe lung disease which would prevent them from providing a breath sample through a large bore tube (e.g., large drinking straw)
- Subjects with uncontrolled diabetes (e.g., ketoacidosis)
- Subjects who are routinely exposed to paints, paint thinners, gasoline, varnishes, glues, dry cleaning solvents, or industrial cleaning products
- Subjects who are daily smokers of cigarettes, e-cigarettes, tobacco products, or marijuana
- Subjects who have consumed alcohol in the previous 24 hours
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
Exhaled chemicals in breath will be compared with COVID status
Time frame: On the day of enrollment, all measurement will be made over the course of 2 hours.
Between subjects with and without COVID, changes in the chemical composition of exhaled breath are correlated with markers of COVID infection: 1) antigen testing of nasal mucous sample and 2) RT-PCR testing of nasal mucous sample.
Measurement of chemical composition in exhaled breath
Time frame: On the day of enrollment, all measurement will be made over the course of 2 hours.
Each subject will provide two breath samples. Each sample will be analyzed by the RISE device.
Assessment of COVID status using nasal swab.
Time frame: On the day of enrollment, all measurement will be made over the course of 2 hours.
Two nasal swabs will be collected for each subject. One nasal swab will be evaluated by antigen testing and the other sample will be analyzed using RT-PCR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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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.
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-19, run by N5 Sensors at 1 site in United States.
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 4 inclusion and 7 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 20 Nov 2024. 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 States. 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 Becca Watson, BS ((425) 261-3547, beccawatson@providence.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled chemicals in breath will be compared with COVID status (time frame: On the day of enrollment, all measurement will be made over the course of 2 hours.). The study lists 3 primary outcomes in all. 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 20 Nov 2024.