Print

Purpose

This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Individuals hospitalized within a Johns Hopkins-affiliated hospital - Able to understand and willingness to comply with study procedures - Cases - inpatients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment - Controls - inpatients without COVID-19 diagnosis and no pulmonary diagnosis or symptoms - Cases or Control not able to sit or stand will be allowed to participate in just the parts of the staircase exam they're capable of doing.

Exclusion Criteria

  • Assisted ventilation, including high flow nasal cannula, or ventilator support - Unable to comply with study procedures, defined at investigator's discretion - Participants with any visible skin infections or open wounds in areas where the imPulse™ Una device would be applied

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Case Inpatients with confirmed COVID-19 with pulmonary symptoms
  • Device: imPulse™ Una e-stethoscope
    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.
  • Device: Philips Lumify Ultrasound System
    Point-of-care ultrasound
Matched Control Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms
  • Device: imPulse™ Una e-stethoscope
    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.
  • Device: Philips Lumify Ultrasound System
    Point-of-care ultrasound

Recruiting Locations

More Details

NCT ID
NCT04556149
Status
Completed
Sponsor
Level 42 AI, Inc.

Detailed Description

This study is designed to evaluate the ability of the imPulse™ Una e-stethoscope to differentiate vibroacoustic signals in inpatients with and without confirmed COVID-19 as the first step to establish the performance characteristics - sensitivity, specificity, positive and negative predictive value - of the imPulse™ Una device for early and rapid, point-of-care diagnosis of COVID-19. This will inform the utility and design of further larger-scale studies using the device.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.