A&M Breathalyzer for COVID-19

(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?

This trial aims to enhance a new COVID-19 detection device that uses a breathalyzer to identify the virus from a person's breath. Researchers seek to determine how effectively this device detects COVID-19 in both symptomatic and asymptomatic individuals, compared to the traditional PCR test. The trial includes two groups: those who have tested positive for COVID-19 and those who have tested negative within the last 48 hours. It suits anyone over 18 who has recently undergone standard COVID-19 testing at Brooke Army Medical Center and can adhere to the trial procedures. As a Phase 2 trial, this research measures the device's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to innovative COVID-19 detection methods.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a breathalyzer device for COVID-19 detection, so it's unlikely that your medications would be affected.

What prior data suggests that the A&M Breathalyzer PROTECT Kiosk is safe for use in detecting COVID-19?

Previous studies have used the A&M Breathalyzer PROTECT Kiosk to detect COVID-19 by analyzing breath samples. This device identifies specific tiny chemical markers in a person's breath. So far, the breathalyzer has been safe, with no reports of significant side effects or problems from its use.

The technology is designed for quick and easy use, without needles or uncomfortable procedures. Participants simply breathe into the system, similar to using a straw. Developers have rapidly advanced this method to make it widely available, prioritizing safety.

While detailed data on side effects from these studies is not available, the absence of reported issues suggests it is well-tolerated. As a diagnostic tool, not a medication, the risk of side effects is generally lower. Ongoing testing aims to improve accuracy and ensure safe use in various settings, such as military environments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PROTECT Kiosk and its A&M Breathalyzer because it offers a non-invasive and rapid way to detect COVID-19. Unlike traditional diagnostic methods such as PCR tests or rapid antigen tests, which require swabs and lab processing, this breathalyzer analyzes a person's breath to identify the presence of the virus. This technology promises to make COVID-19 screening quicker, more comfortable, and potentially more accessible in various settings, from airports to clinics, enhancing our ability to manage and respond to outbreaks efficiently.

What evidence suggests that the A&M Breathalyzer PROTECT Kiosk is effective for detecting COVID-19?

Research has shown that analyzing breath can effectively detect COVID-19. This trial tests the A&M Breathalyzer PROTECT Kiosk for its ability to check breath samples for signs of the virus. Early studies suggest that this device can accurately detect COVID-19 in both symptomatic and asymptomatic individuals. It uses artificial intelligence to identify specific markers of COVID-19 in breath samples. This method aims to offer a quick and easy alternative to traditional tests like swabs. Overall, the A&M Breathalyzer appears promising in identifying COVID-19 quickly and accurately. ^{1 5 6 7 8}

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?

Interventions

• A&M Breathalyzer PROTECT Kiosk

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06402318

Passive Detection- SARS-CoV-2 (COVID-19) A&M ... The A&M Breathalyzer PROTECT Kiosk will collect the mass spectrum breath readings from each participant, scan speed, and will autoanalyze noise and scan ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06402318?cond=Breathalyzer&viewType=Table&rank=4

SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) ... A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers ...

3. tees.tamu.edu tees.tamu.edu/news/2020/11/am-system-worlds-inc-collaborate-on-covid-19-breathalyzer.html

A&M System, Worlds Inc. collaborate on COVID-19 breathalyzer An exhaled breath is key to a new device that uses artificial intelligence to detect whether individuals should be tested for COVID-19.

4. app.trialscreen.org app.trialscreen.org/trials/passive-detection-sars-cov-2-m-breathalyzer-protect-kiosk-operational-study-nct06402318

Passive Detection- SARS-CoV-2 (COVID-19) A&M ... Evaluating the Effectiveness of a Breathalyzer in Detecting COVID-19 Among Symptomatic and Asymptomatic Individuals. Check your eligibility. Share study ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9278167/

Role of Breath Biopsy in COVID-19 Analysis of human breath samples is an attractive strategy for rapid diagnosis of COVID-19 by monitoring breath biomarkers.

6. reaganudall.org reaganudall.org/clinical-trial/passive-detection-sars-cov-2-covid-19-am-breathalyzer-protect-kiosk-operational

SARS-CoV-2 (COVID-19) A&M Breathalyzer The A&M Breathalyzer PROTECT Kiosk will collect the mass spectrum breath readings from each participant, scan speed, and will autoanalyze noise and scan ...

7. dallasinnovates.com dallasinnovates.com/covid-breakthrough-dallas-startup-texas-am-announce-1%E2%80%91breath-screening-device-with-almost-instant-results/

COVID Breakthrough: Dallas Startup, Texas A&M ... A new device may revolutionize COVID-19 screening with breathtaking speed—providing nearly instant results after you blow through a straw.

8. additivemanufacturing.media additivemanufacturing.media/news/essentium-helps-fast-track-covid-19-testing-kiosk

Essentium Helps Fast-Track COVID-19 Testing Kiosk Essentium Helps Fast-Track COVID-19 Testing Kiosk. Company helps speed the design and production of Worlds Protect kiosks for convenient mass ...