Corona Virus InfectionNCT04556149
imPulse™ Una Full-spectrum, Over Clothing E-stethoscope
An observational study of Corona Virus Infection and Coronavirus, run by Level 42 AI, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Corona Virus Infection, Coronavirus
- What is being tested?
- imPulse™ Una e-stethoscope and Philips Lumify Ultrasound System
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 2 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287-5554
About this study
Official title: SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ Una
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.
Read the 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.
- Conditions
- Corona Virus Infection, Coronavirus
- Being tested
- imPulse™ Una e-stethoscope, Philips Lumify Ultrasound System
- Keywords
- infrasound, e-stethoscope, biosignature, SARS-CoV-2/COVID-19
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Philips Lumify Ultrasound SystemDevice
Point-of-care ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Case | Inpatients with confirmed COVID-19 with pulmonary symptoms Receives: Device: imPulse™ Una e-stethoscope; Device: Philips Lumify Ultrasound System | |
| Matched Control | Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms Receives: Device: imPulse™ Una e-stethoscope; Device: Philips Lumify Ultrasound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance characteristics
Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.
Measured: through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Oct 2020
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Level 42 AI, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Schmidt Futures, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Kelly Dooley, MD, PhD, Principal investigator, Johns Hopkins School of MedicineEd Fuchs, MBA, Study director, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556149
- Sponsor's protocol ID
- 00110011
- Status last verified
- Dec 2020
- First submitted
- 23 May 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40733560
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ Una
- ClinicalTrials.gov ID
- NCT04556149
- Acronym / sponsor ID
- 00110011
- Conditions
- Corona Virus Infection, Coronavirus
- Keywords
- infrasound, e-stethoscope, biosignature, SARS-CoV-2/COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Level 42 AI, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Schmidt Futures, Johns Hopkins University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Device: imPulse™ Una e-stethoscope, Device: Philips Lumify Ultrasound SystemInpatients with confirmed COVID-19 with pulmonary symptoms |
| Matched Control | – | Device: imPulse™ Una e-stethoscope, Device: Philips Lumify Ultrasound SystemInpatients without COVID-19 with non-pulmonary diagnoses or symptoms |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imPulse™ Una e-stethoscopeThe 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 | Case, Matched Control |
| Philips Lumify Ultrasound SystemPoint-of-care ultrasound | Device | Case, Matched Control |
Primary outcome
Diagnostic performance characteristics
Time frame: through study completion, an average of 2 weeks
Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Derived from this study: PubMed 40733560Dooley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Dooley, MD, PhD principal investigator
Johns Hopkins School of Medicine
Ed Fuchs, MBA study director
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection and Coronavirus, run by Level 42 AI, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance characteristics (time frame: through study completion, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.