NCT06571136 · N5 Sensors
The Measurement of Chemicals in Exhaled Breath Can Identify If a Person is Infected with COVID-19
What this study is about
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.
View original scientific description
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Everett, Washington
Collaborators
Providence Health & Services, U.S. Department of Homeland Security
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 20, 2024 · Source of record for eligibility and locations