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

December 3, 2025 updated by: The Geneva Foundation

A Prospective, Non-interventional, Observational Clinical Validation Study to Analytically Validate the A&M Breathalyzer PROTECT Kiosk Breath Capture System.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Emerging acute respiratory diseases (ARDs) pose a significant threat for the US military, especially among those in training environments where crowded living conditions and demanding multi-factorial stresses exacerbate infection exposure and suppress immunity, respectively. Consequently, ARD rates are routinely reported higher in recruits than older military personnel, which have a detrimental effect on operational readiness. Although significant steps, such as surveillance and vaccine programs, have been taken to minimize the impact that ARDs have on military recruits and newly mobilized troops, hospitalizations among recruits still exceeds that of comparable civilian population in the United States by at least 3- to 4-folds, accounting for almost 30% of all infectious disease associated hospitalizations. In 2018, respiratory infections like respiratory syncytial virus (RSV), accounted for an estimated 50,000 medical encounters affecting about ~35,000 recruits that resulted in 1,000 hospital bed days leading to significant loss in training time and cost. In addition to annual respiratory infections, the on-going COVID-19 numbers rising again, continues to threaten to further degrade operational readiness. Thus, inexpensive, rapid, and more reliable diagnostics are continually required to better treat and prevent ARDs to preserve military readiness and decrease disability adjusted life years.

Current CLIA laboratory diagnostic procedures, such Enzyme Linked Immunosorbent Assay (ELISA), Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), and bacterial cultures, are costly, time-consuming, and operator sensitive. It has become apparent that during the COVID-19 pandemic, these approaches were and continue to be insufficient in meeting diagnostic needs as they are difficult to scale-up and lack logistical flexibility. Furthermore, due to the invasive nature of active clinical sampling, there is a critical need for accurate and rapid passive surveillance as to screen for SARS-CoV-19 as well as other hazardous chemical and biological agents. To address this capability gap, the current project will: 1) modify and operationalize existing innovative passive surveillance systems that can be deployed in the near-term; 2) leverage revolutionary technologies that will enhance current diagnostic systems to meet mid- and far-term gaps in CBRNE gaps.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Asymptomatic and symptomatic individuals age 18 and older undergoing COVID-19, Flu and/or RSV screening and testing at BAMC, with and without COVID-19.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19, Flu, or RSV positive patients
Participants screened with known COVID-19, Flu or RSV positive results obtained within 48 hours of recruitment.
Device: A&M Breathalyzer PROTECT Kiosk
The A&M Breathalyzer PROTECT Kiosk will collect the mass spectrum breath readings from each participant, scan speed, and will autoanalyze noise and scan thresholds and sensitivity data.
Other Names:
  • Breathalyzer
COVID-19, Flu or RSV negative patients
Participants screened with known COVID-19, Flu or RSV negative results obtained within 48 hours of recruitment.
Device: A&M Breathalyzer PROTECT Kiosk
The A&M Breathalyzer PROTECT Kiosk will collect the mass spectrum breath readings from each participant, scan speed, and will autoanalyze noise and scan thresholds and sensitivity data.
Other Names:
  • Breathalyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration on evaluating the passive sensing, breath capture system built within the A&M Breathalyzer PROTECT Kiosk.
Time Frame: Enrollment through to study completion (min 48hrs through to 12 months)
This evaluation 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.
Enrollment through to study completion (min 48hrs through to 12 months)
Concentration on optimization and operationalizing the A&M Breathalyzer PROTECT Kiosk
Time Frame: Enrollment through to study completion (min 48hrs through to 12 months)
Optimization and operationalize the A&M Breathalyzer PROTECT Kiosk, to test its detection capabilities of COVID-19, Flu, and/or RSV among symptomatic and asymptomatic COVID-19, Flu or RSV carrier vs. those not infected compared to gold standard RT-PCR.
Enrollment through to study completion (min 48hrs through to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Geneva Foundation

Collaborators

Uniformed Services University of the Health Sciences
Brooke Army Medical Center
Level 42 AI, Inc.

Investigators

  • Principal Investigator: Michael Morris, MD, Brooke Army Medical Center
  • Principal Investigator: Tony Yuan, PhD, Uniformed Services University of the Health Sciences (USUHS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2024.007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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