SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to evaluate new non-invasive passive surveillance technologies, Level 42 AI imPulse™ for the detection of COVID-19 in asymptomatic and symptomatic individuals over age of 18 undergoing COVID-19 screening and testing at BAMC Ft Sam Houston, TX; with and without COVID-19. The hypotheses are: (H1) The imPulse™ Una e-stethoscope has at least a similar discriminative and detection ability among symptomatic and asymptomatic COVID-19 carrier versus those not infected compared to gold standard RT-PCR. Based on these promising studies, we will operationalize and deploy the imPulseTM Una e-stethoscope and other associated technology form factors into DoD use-cases. (H2) In the mid to long-term, this approach will also be explored as a diagnostic system to explore pursue the physical (structural and mechanical) properties of cells and tissues that maintain normal cell behavior (motility, growth, apoptosis), and the critical importance of the ability of cells to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures in austere environments. Participants will: Be consented; Be screened for COVID-19 symptoms according to BAMC's current screening procedures; Have study data collected; Complete a COVID-19 symptoms questionnaire; imPulseTM Una e-stethoscope examination will be conducted; Participants will be compensated for completing all study requirements. (Active-Duty personnel must complete the study procedures while off-duty in order to receive compensation.)

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. 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 gold standard laboratory procedures for respiratory infection detection are costly, time-consuming, and operator sensitive. It has become apparent that 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 aims to deploy novel innovative passive surveillance systems into existing COVID-19 testing lines to validate previous results and validate operational utilization. The DoD needs fast, accurate, non-invasive, readily scalable, mass screening actionable tests that drive decisions leading to better human, structure, and equipment health outcomes. The required diagnostic tests should first, provide accurate diagnostic information, and second- the diagnostic information, when used in decision-making, should improve human, structure, and equipment health outcomes in a clinically quantifiable way. The Level 42 AI imPulse™ over-clothing e-stethoscope and stand-off systems are intended to be used to identify characteristic and subtle changes in audible and inaudible sounds changes in the upper and lower respiratory tract driven by airflow velocity, hydration, pressure, and wall shear stress for both inspiration (velocity splitting) and expiration (velocity merging) during active infection vs. health.

Official Title
-----------------
SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies

Conditions
-----------------
Corona Virus Infection, COVID-19, SARS-CoV-2 Virus, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic and symptomatic individuals 18 years and older Receiving standard COVID-19 screening and testing at BAMC Do not have to be diagnosed with SARS-CoV-19 (COVID-19) but only be screened English Speaking Exclusion Criteria: 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 3-minute vibroacoustic scan

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 positive patients<br>Participants screened with known COVID-19 positive test results obtained within 48hrs of recruitment. | Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope<br>* The imPulse™ System is an every/anywhere-point-of-care cardiopulmonary functional state assessment platform designed to capture normal and abnormal, audible and inaudible cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum phonocardiogram obtained from direct to skin coupling or through a layer of clothing.<br>* Other names: Passive Detection;|
| COVID-19 negative patients<br>Participants screened with known COVID-19 negative test results obtained within 48hrs of recruitment. | Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope<br>* The imPulse™ System is an every/anywhere-point-of-care cardiopulmonary functional state assessment platform designed to capture normal and abnormal, audible and inaudible cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum phonocardiogram obtained from direct to skin coupling or through a layer of clothing.<br>* Other names: Passive Detection;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital vibroacoustic biomarker diagnostic performance characteristics | Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19 among symptomatic and asymptomatic COVID-19 carrier versus those not infected compared to gold standard RT-PCR. | Enrollment through to study completion (min 48hrs through to 12 months) | 
| imPulse™ Una infrasound-to-ultrasound e-stethoscope device usability | Critical importance of the ability to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures in austere environments | Enrollment through to study completion (min 48hrs through to 12 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2 detection, COVID-19 diagnostic product, e-stethoscope, military