Official Title
Identification of COVID-19 Infection from Measurement of Exhaled Breath
Brief Summary

The type and number of chemicals in exhaled breath are different in people with infectionas compared to those without infection. In this study, the breath of people with andwithout COVID infection will be measured. Changes in the amount and type of chemicals inbreath 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 maybe 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.

Recruiting
COVID-19
Eligibility Criteria

Inclusion Criteria:

1. Subject must complete the consent process

2. Subjects of both sexes must be ≥ 18 and ≤ 70 years old

3. Control subjects must have negative RT-PCR and antigen test

4. COVID subjects must have a positive RT-PCR and/or antigen test.

Exclusion Criteria:

1. Subjects with severe lung disease which would prevent them from providing a breath
sample through a large bore tube (e.g., large drinking straw)

2. Subjects with uncontrolled diabetes (e.g., ketoacidosis)

3. Subjects who are routinely exposed to paints, paint thinners, gasoline, varnishes,
glues, dry cleaning solvents, or industrial cleaning products

4. Subjects who are daily smokers of cigarettes, e-cigarettes, tobacco products, or
marijuana

5. Subjects who have consumed alcohol in the previous 24 hours

6. 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,

7. Subjects who are experiencing respiratory failure

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 70 Years
Countries
United States
Locations

Providence Regional Medical Center Everett
Everett, Washington, United States

Investigator: Rebecca Watson, BS
Contact: 425-261-3547
beccawatson@providence.org

Contacts

Becca Watson, BS
(425) 261-3547
beccawatson@providence.org

Not Provided

NCT Number
Keywords
Breath testing
Covid-19
Nasal Swab
MeSH Terms
COVID-19