COVID-19COVID-19NCT06402318
Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine
An observational study of COVID-19 and SARS CoV 2 Virus, run by The Geneva Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS CoV 2 Virus, COVID-19 Pneumonia
- What is being tested?
- A&M Breathalyzer PROTECT Kiosk
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2023to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Katherine Walker-Rodriguez, MSN, 2103783057, katherine.c.walker-rodriguez.ctr@health.mil
Tony Yuan, PhD, tony.yuan@usuhs.edu
About this study
Official title: A Prospective, Non-interventional, Observational Clinical Validation Study to Analytically Validate the A&M Breathalyzer PROTECT Kiosk Breath Capture System.
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.
Read more
Goals:
- 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.
- 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.
Read the detailed description
Emerging acute respiratory diseases (ARDs) pose a significant threat for the US military, especially among those in training environments where crowded living conditions and demanding multi-factorial stresses exacerbate infection exposure and suppress immunity, respectively. Consequently, ARD rates are routinely reported higher in recruits than older military personnel, which have a detrimental effect on operational readiness. Although significant steps, such as surveillance and vaccine programs, have been taken to minimize the impact that ARDs have on military recruits and newly mobilized troops, hospitalizations among recruits still exceeds that of comparable civilian population in the United States by at least 3- to 4-folds, accounting for almost 30% of all infectious disease associated hospitalizations. In 2018, respiratory infections like respiratory syncytial virus (RSV), accounted for an estimated 50,000 medical encounters affecting about ~35,000 recruits that resulted in 1,000 hospital bed days leading to significant loss in training time and cost. In addition to annual respiratory infections, the on-going COVID-19 numbers rising again, continues to threaten to further degrade operational readiness. Thus, inexpensive, rapid, and more reliable diagnostics are continually required to better treat and prevent ARDs to preserve military readiness and decrease disability adjusted life years.
Current CLIA laboratory diagnostic procedures, such Enzyme Linked Immunosorbent Assay (ELISA), Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), and bacterial cultures, are costly, time-consuming, and operator sensitive. It has become apparent that during the COVID-19 pandemic, these approaches were and continue to be insufficient in meeting diagnostic needs as they are difficult to scale-up and lack logistical flexibility. Furthermore, due to the invasive nature of active clinical sampling, there is a critical need for accurate and rapid passive surveillance as to screen for SARS-CoV-19 as well as other hazardous chemical and biological agents. To address this capability gap, the current project will: 1) modify and operationalize existing innovative passive surveillance systems that can be deployed in the near-term; 2) leverage revolutionary technologies that will enhance current diagnostic systems to meet mid- and far-term gaps in CBRNE gaps.
- Conditions
- COVID-19, SARS CoV 2 Virus, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome
- Being tested
- A&M Breathalyzer PROTECT Kiosk
- Keywords
- Breathalyzer, COVID-19 detection, Diagnostic Product, Pulmonary, PROTECT Kiosk, Passive Detection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A&M Breathalyzer PROTECT KioskDevice
Also called 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 thresholds and sensitivity data.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19, Flu, or RSV positive patients | Participants screened with known COVID-19, Flu or RSV positive results obtained within 48 hours of recruitment. Receives: 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. Receives: Device: A&M Breathalyzer PROTECT Kiosk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Enrollment through to study completion (min 48hrs through to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start27 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Geneva Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Brooke Army Medical Center, Uniformed Services University of the Health Sciences, Level 42 AI, Inc.
- Responsible party
- Sponsor
- Investigators
- Tony Yuan, PhD, Principal investigator, Uniformed Services University of the Health Sciences (USUHS)Michael Morris, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402318
- Sponsor's protocol ID
- C.2024.007
- Acronym
- COVID-19
- Status last verified
- Jan 2025
- First submitted
- 3 May 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26524104Grassin-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.
PubMed 33279860Zamora-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.
PubMed 34635222van 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.
PubMed 31858615
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Observational Clinical Validation Study to Analytically Validate the A&M Breathalyzer PROTECT Kiosk Breath Capture System.
- ClinicalTrials.gov ID
- NCT06402318
- Acronym / sponsor ID
- COVID-19 / C.2024.007
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Geneva FoundationUniversity, hospital or other
- Collaborators
- Brooke Army Medical Center, Uniformed Services University of the Health Sciences, Level 42 AI, Inc.
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
Emerging acute respiratory diseases (ARDs) pose a significant threat for the US military, especially among those in training environments where crowded living conditions and demanding multi-factorial stresses exacerbate infection exposure and suppress immunity, respectively. Consequently, ARD rates are routinely reported higher in recruits than older military personnel, which have a detrimental effect on operational readiness. Although significant steps, such as surveillance and vaccine programs, have been taken to minimize the impact that ARDs have on military recruits and newly mobilized troops, hospitalizations among recruits still exceeds that of comparable civilian population in the United States by at least 3- to 4-folds, accounting for almost 30% of all infectious disease associated hospitalizations. In 2018, respiratory infections like respiratory syncytial virus (RSV), accounted for an estimated 50,000 medical encounters affecting about ~35,000 recruits that resulted in 1,000 hospital bed days leading to significant loss in training time and cost. In addition to annual respiratory infections, the on-going COVID-19 numbers rising again, continues to threaten to further degrade operational readiness. Thus, inexpensive, rapid, and more reliable diagnostics are continually required to better treat and prevent ARDs to preserve military readiness and decrease disability adjusted life years.
Current CLIA laboratory diagnostic procedures, such Enzyme Linked Immunosorbent Assay (ELISA), Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), and bacterial cultures, are costly, time-consuming, and operator sensitive. It has become apparent that during the COVID-19 pandemic, these approaches were and continue to be insufficient in meeting diagnostic needs as they are difficult to scale-up and lack logistical flexibility. Furthermore, due to the invasive nature of active clinical sampling, there is a critical need for accurate and rapid passive surveillance as to screen for SARS-CoV-19 as well as other hazardous chemical and biological agents. To address this capability gap, the current project will: 1) modify and operationalize existing innovative passive surveillance systems that can be deployed in the near-term; 2) leverage revolutionary technologies that will enhance current diagnostic systems to meet mid- and far-term gaps in CBRNE gaps.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19, Flu, or RSV positive patients | – | Device: A&M Breathalyzer PROTECT KioskParticipants screened with known COVID-19, Flu or RSV positive results obtained within 48 hours of recruitment. |
| COVID-19, Flu or RSV negative patients | – | Device: A&M Breathalyzer PROTECT KioskParticipants screened with known COVID-19, Flu or RSV negative results obtained within 48 hours of recruitment. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A&M Breathalyzer PROTECT KioskAlso: BreathalyzerThe 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. | Device | COVID-19, Flu or RSV negative patients, COVID-19, Flu, or RSV positive patients |
Primary outcome
Concentration on optimization and operationalizing the A&M Breathalyzer PROTECT Kiosk
Time frame: Enrollment through to study completion (min 48hrs through to 12 months)
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.
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Background: PubMed 26524104Anderson 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.
- Background: PubMed 33279860Grassin-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.
- Background: PubMed 34635222Zamora-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.
- Background: PubMed 31858615van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tony Yuan, PhD principal investigator
Uniformed Services University of the Health Sciences (USUHS)
Michael Morris, MD principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS CoV 2 Virus, run by The Geneva Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tony Yuan, PhD (214-292-0508, tony.yuan@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06402318, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.