The Measurement of Chemicals in Exhaled Breath Can Identify If a Person is Infected with COVID-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: COVID-19. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Identification of COVID-19 Infection from Measurement of Exhaled Breath
Overview
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.
Primary outcome measures
- 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.]
- 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.]
- 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Providence Regional Medical Center Everett — Everett
Identifiers
NCT: NCT06571136 · N5-202401 · 70RSAT22C00000019