Recruiting

COVID-19 Detection

Sponsor:

The Geneva Foundation

Code:

NCT06402318

Conditions

COVID-19

SARS CoV 2 Virus

COVID-19 Pneumonia

COVID-19 Respiratory Infection

COVID-19 Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

A&M Breathalyzer PROTECT Kiosk

Study Details

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. 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.

Conditions

COVID-19

SARS CoV 2 Virus

COVID-19 Pneumonia

COVID-19 Respiratory Infection

COVID-19 Acute Respiratory Distress Syndrome

Study ID

NCT06402318

Start date

Dec 27, 2023

Status verified date

Jan, 2025

Completion date

Mar 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

COVID-19, Flu, or RSV positive patients

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

COVID-19, Flu or RSV negative patients

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

Interventions

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.

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) ]
  • 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) ]

Central Contacts and Locations

Locations

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Principal Investigator:

Michael Morris, MD

More Information

Sponsor

The Geneva Foundation

Last update posted

Dec 10, 2025

Last verified

Jan, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by The Geneva Foundation on 2025-12-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.