Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Schmidt Futures | UNKNOWN |
| Johns Hopkins University | OTHER |
Not provided
Not provided
Not provided
Not provided
This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulseâ„¢ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.
This study is designed to evaluate the ability of the imPulseâ„¢ 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 imPulseâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Inpatients with confirmed COVID-19 with pulmonary symptoms |
| |
| Matched Control | Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imPulseâ„¢ Una e-stethoscope | Device | The imPulseâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance characteristics | Sensitivity, specificity, positive and negative predictive values - of the imPulseâ„¢ Una device for point-of-care diagnosis of COVID-19. | through study completion, an average of 2 weeks |
Not provided
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kelly Dooley, MD, PhD | Johns Hopkins School of Medicine | Principal Investigator |
| Ed Fuchs, MBA | Johns Hopkins School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21287-5554 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40733560 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Philips Lumify Ultrasound System | Device | Point-of-care ultrasound |
|
| D007239 |
| Infections |