Recruiting

Observational Study

Sponsor:

N5 Sensors

Code:

NCT06571136

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Study Details

Brief 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. 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.

Conditions

COVID-19

Study ID

NCT06571136

Start date

Aug 19, 2024

Status verified date

Aug, 2024

Completion date

Feb 26, 2025

Anticipated

Primary completion date

Feb 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Locations

Providence Regional Medical Center Everett

Recruiting

Everett, Washington, United States, 98201

Contacts

More Information

Sponsor

N5 Sensors

Last update posted

Nov 20, 2024

Last verified

Aug, 2024

Keywords

  • Breath testing
  • COVID-19
  • Nasal swab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by N5 Sensors on 2024-11-20.