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

(COVID-19 Trial)

Overseen By Katherine Walker-Rodriguez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Geneva Foundation

Disqualifiers: Under 18, Non-compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Tony Yuan, PhD

Principal Investigator

Uniformed Services University of the Health Sciences (USUHS)

Michael Morris, MD

Principal Investigator

Brooke Army Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am getting regular COVID-19 tests at BAMC.

I have been screened for COVID-19 but not necessarily diagnosed.

I understand the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Evaluation

Evaluation of the passive sensing, breath capture system built within the A&M Breathalyzer PROTECT Kiosk

12 months

Multiple visits (in-person)

Optimization

Optimization and operationalization of the A&M Breathalyzer PROTECT Kiosk to test its detection capabilities

12 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after evaluation and optimization

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: COVID-19 positive patients Experimental Treatment 1 Intervention

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

Group II: COVID-19 negative patients Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

The Geneva Foundation

Lead Sponsor

Trials

39

Recruited

13,700+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Level 42 AI, Inc.

Industry Sponsor

Trials

6

Recruited

1,400+