NCT04556149

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

May 23, 2020

Last Update Submit

December 17, 2020

Conditions

Corona Virus InfectionCoronavirus

Keywords

infrasounde-stethoscopebiosignatureSARS-CoV-2/COVID-19

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance characteristics

    Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.

    through study completion, an average of 2 weeks

Study Arms (2)

Case

Inpatients with confirmed COVID-19 with pulmonary symptoms

Device: imPulse™ Una e-stethoscopeDevice: Philips Lumify Ultrasound System

Matched Control

Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms

Device: imPulse™ Una e-stethoscopeDevice: Philips Lumify Ultrasound System

Interventions

imPulse™ Una e-stethoscopeDEVICE

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.

CaseMatched Control
Philips Lumify Ultrasound SystemDEVICE

Point-of-care ultrasound

CaseMatched Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult men and women will be recruited from among hospitalized patients with symptomatic COVID-19 infection who are not receiving ventilator support. One hospitalized control without lung disease or pulmonary symptoms will be selected for each case.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287-5554, United States

Location

Related Publications (1)

  • Dooley KE, Morimoto M, Kaszuba P, Krasne M, Liu G, Fuchs E, Rexelius P, Swan J, Krawiec K, Hammond K, Ray SC, Hafen R, Schuh A, Jumbe NLS. Evidence Generation for a Host-Response Biosignature of Respiratory Disease. Viruses. 2025 Jul 2;17(7):943. doi: 10.3390/v17070943.

    PMID: 40733560DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Kelly Dooley, MD, PhD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

  • Ed Fuchs, MBA

    Johns Hopkins School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2020

First Posted

September 21, 2020

Study Start

October 1, 2020

Primary Completion

December 2, 2020

Study Completion

December 2, 2020

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)