The Measurement of Chemicals in Exhaled Breath Can Identify If a Person is Infected with COVID-19

NCT06571136 | Recruiting

• 2 other identifiers: N5-20240170RSAT22C00000019
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Breath testing; COVID-19; Nasal swab

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  On the day of enrollment, all measurement will be made over the course of 2 hours.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who present at a regional emergency department

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• N5 Sensors: lead
• Providence Health & Services: collaborator
• U.S. Department of Homeland Security: collaborator

Study Sites (1)

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Becca Watson, BS

CONTACT

(425) 261-3547; beccawatson@providence.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 26, 2024
• Study Start: August 19, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 26, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-08

Locations

US (1)