Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine

Recruiting now

Conditions studied: COVID-19, SARS CoV 2 Virus, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome

In brief

The primary objective of this effort will be to optimize and operationalize innovative passive surveillance systems and in parallel, the effort will identify, evaluate, and transition groundbreaking new technologies in diagnostics for operationalization. To meet the objective and execute the deliverables for this program of effort, the A\&M Breathalyzer PROTECT Kiosk will be tested, modified and validated at Brooke Army Medical Center (BAMC). The collaborative efforts between the PI, Dr. Michael Morris at BAMC and Co-Investigator Dr. Tony Yuan at USU- Center for Biotechnology (4D Bio3) will assess the passive detection technology and provide a capability survey of use-case scenarios for different operational settings. Goals: 1. Optimization and operationalize the A\&M Breathalyzer PROTECT Kiosk, portable mass spectrometer (MS) Detector for Deployment in Military Operational Medicine Environments. The Breathalyzer will be deployed to BAMC to test its detection capabilities of COVID-19 among symptomatic and asymptomatic COVID-19 carrier vs. those not infected compared to gold standard RT-PCR. 2. Evaluate the passive sensing, breath capture system, built within the A\&M Breathalyzer PROTECT Kiosk. The conversion of the active breath capture system, currently requires a straw that the subject breaths into, where then a series of sensors built in the Breathalyzer would automatically sample the exhaled breath within proximity for recent COVID-19 exposure. This task would conclude with a set of sensors and sensor inputs that would be analyzed by the Atomic AI platform built in the device. Field testing at BAMC is planned to determine the level of detection and discrimination for sensor combinations to SARS-CoV2 components and biomarkers detected. This testing would update the Atomic AI algorithm, within the device, to understand the accuracy of positive detection and the resulting sensitivities.

Key facts

Study ID

NCT06402318

Run by

The Geneva Foundation

People needed

100

Starts

2023-12-27

Expected to finish

2026-03-30

Last updated by the study team

2025-12-10

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Asymptomatic and symptomatic individuals 18 years and older
• Receiving standard COVID-19, Flu and/or RSV screening and testing at BAMC
• Do not have to be diagnosed with SARS-CoV-19 (COVID-19) but only be screened
• Ability to understand consent

You may not qualify if…

• Any individual under age of 18
• Anyone unable to comply (or be assisted) with study procedures
• Anyone not able to provide temperature thermal scan, and/or perform exhaled breath for approximately 8 seconds

Where it is running

• Brooke Army Medical Center — Fort Sam Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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