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

NCT06402318 | Recruiting

• 1 other identifier: C.2024.007
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

COVID-19; SARS CoV 2 Virus; COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Acute Respiratory Distress Syndrome

Keywords

Breathalyzer; COVID-19 detection; Diagnostic Product; Pulmonary; PROTECT Kiosk; Passive Detection

Outcome Measures

Primary Outcomes (2)

• Concentration on optimization and operationalizing the A&M Breathalyzer PROTECT Kiosk

  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)

• Concentration on evaluating the passive sensing, breath capture system built within the A&M Breathalyzer PROTECT Kiosk.

  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)

Study Arms (2)

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

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

Interventions

A&M Breathalyzer PROTECT Kiosk DEVICE

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.

Also known as: Breathalyzer

COVID-19, Flu or RSV negative patients; COVID-19, Flu, or RSV positive patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• The Geneva Foundation: lead
• Brooke Army Medical Center: collaborator
• Uniformed Services University of the Health Sciences: collaborator
• Level 42 AI, Inc.: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

Related Publications (4)

• Anderson JC. Measuring breath acetone for monitoring fat loss: Review. Obesity (Silver Spring). 2015 Dec;23(12):2327-34. doi: 10.1002/oby.21242. Epub 2015 Nov 2.

  PMID: 26524104 BACKGROUND

• Grassin-Delyle S, Roquencourt C, Moine P, Saffroy G, Carn S, Heming N, Fleuriet J, Salvator H, Naline E, Couderc LJ, Devillier P, Thevenot EA, Annane D; Garches COVID-19 Collaborative Group RECORDS Collaborators and Exhalomics(R) Collaborators. Metabolomics of exhaled breath in critically ill COVID-19 patients: A pilot study. EBioMedicine. 2021 Jan;63:103154. doi: 10.1016/j.ebiom.2020.103154. Epub 2020 Dec 4.

  PMID: 33279860 BACKGROUND

• Zamora-Mendoza BN, Diaz de Leon-Martinez L, Rodriguez-Aguilar M, Mizaikoff B, Flores-Ramirez R. Chemometric analysis of the global pattern of volatile organic compounds in the exhaled breath of patients with COVID-19, post-COVID and healthy subjects. Proof of concept for post-COVID assessment. Talanta. 2022 Jan 1;236:122832. doi: 10.1016/j.talanta.2021.122832. Epub 2021 Sep 2.

  PMID: 34635222 BACKGROUND

• van Keulen KE, Jansen ME, Schrauwen RWM, Kolkman JJ, Siersema PD. Volatile organic compounds in breath can serve as a non-invasive diagnostic biomarker for the detection of advanced adenomas and colorectal cancer. Aliment Pharmacol Ther. 2020 Feb;51(3):334-346. doi: 10.1111/apt.15622. Epub 2019 Dec 20.

  PMID: 31858615 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Breath Tests

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Tony Yuan, PhD

  Uniformed Services University of the Health Sciences (USUHS)

  PRINCIPAL INVESTIGATOR

• Michael Morris, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Yuan, PhD

CONTACT

214-292-0508; tony.yuan@usuhs.edu

Katherine Walker-Rodriguez

CONTACT

2103783057; katherine.c.walker-rodriguez.ctr@health.mil

Study Design

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

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: December 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)