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

Part of paid clinical trials in Fort Sam Houston, Texas.

Sponsor
The Geneva Foundation
Study ID
NCT06402318
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

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.

Study Details

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 Dates

Start date
Dec 27, 2023
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Mar 30, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: COVID-19, Flu, or RSV positive patients
    Participants screened with known COVID-19, Flu or RSV positive results obtained within 48 hours of recruitment.
  • Arm: COVID-19, Flu or RSV negative patients
    Participants screened with known COVID-19, Flu or RSV negative results obtained within 48 hours of recruitment.

Primary Outcome Measure

Concentration on optimization and operationalizing the A&M Breathalyzer PROTECT Kiosk [ Time Frame: Enrollment through to study completion (min 48hrs through to 12 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brooke Army Medical CenterFort Sam HoustonTexas78234
Katherine Walker-Rodriguez, MSN
[email protected]
2103783057
Tony Yuan, PhD
[email protected]
Michael Morris, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fort Sam Houston, TX

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Brooke Army Medical Center· Fort Sam Houston, TX

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