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COVID-19 negative patients for COVID-19 (COVID-19 Trial)

N/A
Recruiting
Led By Michael Morris, MD
Research Sponsored by The Geneva Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment through to study completion (min 48hrs through to 12 months)
Awards & highlights

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: 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.

Eligible Conditions
  • COVID-19
  • Coronavirus Disease
  • Coronavirus Pneumonia
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment through to study completion (min 48hrs through to 12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through to study completion (min 48hrs through to 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentration on evaluating the passive sensing, breath capture system built within the A&M Breathalyzer PROTECT Kiosk.
Concentration on optimization and operationalizing the A&M Breathalyzer PROTECT Kiosk

Trial Design

2Treatment groups
Experimental Treatment
Group I: COVID-19 positive patientsExperimental Treatment1 Intervention
Participants screened with known COVID-19 positive results obtained within 48 hours of recruitment.
Group II: COVID-19 negative patientsExperimental Treatment1 Intervention
Participants screened with known COVID-19 negative results obtained within 48 hours of recruitment.

Find a Location

Who is running the clinical trial?

The Geneva FoundationLead Sponsor
33 Previous Clinical Trials
12,648 Total Patients Enrolled
1 Trials studying COVID-19
300 Patients Enrolled for COVID-19
Brooke Army Medical CenterFED
121 Previous Clinical Trials
26,159 Total Patients Enrolled
1 Trials studying COVID-19
300 Patients Enrolled for COVID-19
Uniformed Services University of the Health SciencesFED
122 Previous Clinical Trials
90,444 Total Patients Enrolled
3 Trials studying COVID-19
500 Patients Enrolled for COVID-19
~42 spots leftby Dec 2024