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NCT06402318 · ClinicalTrials.gov registry record

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

A clinical trial of COVID-19 and COVID-19 Respiratory Infection, sponsored by The Geneva Foundation.

Recruiting
Registry status
100
Enrollment target
1
Study location

NCT06402318: Recruiting study of COVID-19 and COVID-19 Respiratory Infection, sponsored by The Geneva Foundation.

NCT06402318 is a study of COVID-19 and COVID-19 Respiratory Infection that is actively recruiting participants, run by The Geneva Foundation. The registered enrollment target is 100 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06402318, a study of COVID-19 and COVID-19 Respiratory Infection, is actively recruiting participants, sponsored by The Geneva Foundation.

RECRUITING
Registry status
100 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Interventions

  • DEVICE A&M Breathalyzer PROTECT Kiosk

Study Locations (1)

Texas

  • Brooke Army Medical Center - Fort Sam Houston

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-12-27
Est. Completion 2026-03-30
The Geneva Foundation

11 total trials

What NCT06402318 shows while recruiting

NCT06402318 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).

The record links to 5 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which A&M Breathalyzer PROTECT Kiosk is the first listed.

NCT06402318 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06402318 about?

NCT06402318 is a clinical study titled "Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine". 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 delive...

What is the current status of trial NCT06402318?

This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2023-12-27. Estimated completion is 2026-03-30.

What conditions does trial NCT06402318 study?

This clinical trial studies the following conditions: COVID-19, COVID-19 Respiratory Infection, COVID-19 Pneumonia, COVID-19 Acute Respiratory Distress Syndrome, SARS-CoV-2 Virus.

What interventions are being tested in trial NCT06402318?

The interventions under investigation include: A&M Breathalyzer PROTECT Kiosk (DEVICE).

Who is sponsoring clinical trial NCT06402318?

This trial is sponsored by The Geneva Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06402318 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for COVID-19

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06402318's enrollment target sits among peer trials

100 201st of 298 higher than 96 of 298 other COVID-19 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06402318, the US trial registry maintained by the National Library of Medicine. NCT06402318 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.