Covid19NCT04941209
imPulse™ Una Infrasound-to-ultrasound E-stethoscope
An observational study of Covid19 and COVID-19 Pneumonia, run by Level 42 AI, Inc. at 3 sites in 3 countries.
Trial summary
This study generates robust, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of asymptomatic and symptomatic COVID-19 digital biosignatures for rapid and accurate adult and… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection
- What is being tested?
- imPulse™ Una infrasound-to-ultrasound e-stethoscope, (PPA >95%) FDA EUA RT-PCR and HR-CT-scan
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 702 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 11 Jun 2021to 28 Feb 2022
- 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 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: Women/girls and men/boys meeting enrollment criteria will be recruited from among hospitalized inpatients and outpatients with asymptomatic and symptomatic COVID-19 infection. One outpatient control without lung disease or pulmonary symptoms will be selected for each enrolled case.
Who may be able to join
- Able to understand and willingness to comply with study procedures
- Inpatient Cases - hospitalized patients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment
- Outpatient Cases - participant being screened for COVID-19 with positive COVID-19 PCR test respiratory sample Controls - Outpatients with negative COVID-19 PCR test respiratory sample 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
3 sites in 3 countries.
3 sites in 3 countries
Democratic Republic of the Congo1 site
Laboratoire de la foundation Gombes
Pointe Noire, Kouilou
Senegal1 site
Institute for Health Research, Epidemiological Surveillance and Training ( IRESSEF)
Dakar, Almadies
About this study
Official title: imPulse™ Una Infrasound-to-ultrasound E-stethoscope 2-minute to Result COVID-19 Self-directed & Point-of-care Screening Test
This study generates robust, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of asymptomatic and symptomatic COVID-19 digital biosignatures for rapid and accurate adult and child mass screening.
Read the detailed description
For the next few years or more, the planet probably won't have enough vaccine for everyone. Even as countries with large COVID-19 vaccination programs start pushing to resume travel and trade:
We will not know who is vaccinated and who is not . We will not know who is an (a)symptomatic COVID-19 carrier and who is not.
Because of this, the global community will remain in various stages of masking, social distancing, lock-down, and limited congregation because of cyclical COVID-19 spikes and people will continue to feel unsafe and afraid as novel COVID-19 variants appear and disappear.
This large-scale, multi-site, multi-national study is informed by a completed pilot study at Johns Hopkins- NCT04556149. This study is designed to validate the ability of the imPulse™ Una infrasound-to-ultrasound e-stethoscope to rapidly and accurately screen outpatients with and without confirmed COVID-19 with sensitivity, specificity, positive and negative predictive value matching (PPA >95%) for early, accurate, and rapid, self-directed and point-of-care diagnosis of COVID-19 in areas still lagging in access to vaccines.
- Conditions
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome, Mass Screening, Corona Virus Infection
- Being tested
- imPulse™ Una infrasound-to-ultrasound e-stethoscope, (PPA >95%) FDA EUA RT-PCR, HR-CT-scan
- Keywords
- infrasound, ultrasound, vibroacoustics, vibrome, digital-biosignature, e-stethoscope
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imPulse™ Una infrasound-to-ultrasound 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.
(PPA >95%) FDA EUA RT-PCRDiagnostic test
Also called RT-PCR
Real-time RT-PCR that detects amplified SARS-CoV-2 genome in sputum, nasopharyngeal or oropharyngeal swabs, bronchoalveolar lavage fluid, nasal or nasopharyngeal aspirate, and lower respiratory tract aspirates.
HR-CT-scanRadiation
Also called CT, CAT
High-resolution computer tomography, or CT/CAT, is an X-ray scan that produces images of the chest and is used as a confirmatory test in symptomatic patients that have a negative PCR test.
| Study group | Role | What they receive |
|---|---|---|
| Case | Inpatients/Outpatients with confirmed COVID-19 with and without pulmonary symptoms. Receives: Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope; Diagnostic Test: (PPA >95%) FDA EUA RT-PCR; Radiation: HR-CT-scan | |
| Matched-Control | Outpatients without COVID-19 without known non-pulmonary diagnoses or symptoms. Receives: Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope; Diagnostic Test: (PPA >95%) FDA EUA RT-PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment through to study completion (min 48hrs through to 3 months)
Secondary outcomes (1)
imPulse™ Una infrasound-to-ultrasound e-stethoscope device safety
Device safety
Measured: Enrollment through to study completion (min 48hrs through to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start11 Jun 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Level 42 AI, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asian Institute of Public Health, Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation (IRESSEF), Laboratoire de la foundation Gombes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941209
- Sponsor's protocol ID
- L42AI-20210003
- Status last verified
- May 2022
- First submitted
- 20 Jun 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- imPulse™ Una Infrasound-to-ultrasound E-stethoscope 2-minute to Result COVID-19 Self-directed & Point-of-care Screening Test
- ClinicalTrials.gov ID
- NCT04941209
- Acronym / sponsor ID
- L42AI-20210003
- Conditions
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome, Mass Screening, Corona Virus Infection
- Keywords
- infrasound, ultrasound, vibroacoustics, vibrome, digital-biosignature, e-stethoscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Level 42 AI, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Asian Institute of Public Health, Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation (IRESSEF), Laboratoire de la foundation Gombes
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 28 Jun 2021 (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, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of asymptomatic and symptomatic COVID-19 digital biosignatures for rapid and accurate adult and child mass screening.
Detailed description
For the next few years or more, the planet probably won't have enough vaccine for everyone. Even as countries with large COVID-19 vaccination programs start pushing to resume travel and trade:
We will not know who is vaccinated and who is not . We will not know who is an (a)symptomatic COVID-19 carrier and who is not.
Because of this, the global community will remain in various stages of masking, social distancing, lock-down, and limited congregation because of cyclical COVID-19 spikes and people will continue to feel unsafe and afraid as novel COVID-19 variants appear and disappear.
This large-scale, multi-site, multi-national study is informed by a completed pilot study at Johns Hopkins- NCT04556149. This study is designed to validate the ability of the imPulse™ Una infrasound-to-ultrasound e-stethoscope to rapidly and accurately screen outpatients with and without confirmed COVID-19 with sensitivity, specificity, positive and negative predictive value matching (PPA >95%) for early, accurate, and rapid, self-directed and point-of-care diagnosis of COVID-19 in areas still lagging in access to vaccines.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope, Diagnostic Test: (PPA >95%) FDA EUA RT-PCR, Radiation: HR-CT-scanInpatients/Outpatients with confirmed COVID-19 with and without pulmonary symptoms. |
| Matched-Control | – | Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope, Diagnostic Test: (PPA >95%) FDA EUA RT-PCROutpatients without COVID-19 without known non-pulmonary diagnoses or symptoms. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Women/girls and men/boys meeting enrollment criteria will be recruited from among hospitalized inpatients and outpatients with asymptomatic and symptomatic COVID-19 infection. One outpatient control without lung disease or pulmonary symptoms will be selected for each enrolled case.
Key inclusion criteria (3 listed)
- Able to understand and willingness to comply with study procedures
- Inpatient Cases - hospitalized patients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment
- Outpatient Cases - participant being screened for COVID-19 with positive COVID-19 PCR test respiratory sample Controls - Outpatients with negative COVID-19 PCR test respiratory sample 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 infrasound-to-ultrasound 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 |
| (PPA >95%) FDA EUA RT-PCRAlso: RT-PCRReal-time RT-PCR that detects amplified SARS-CoV-2 genome in sputum, nasopharyngeal or oropharyngeal swabs, bronchoalveolar lavage fluid, nasal or nasopharyngeal aspirate, and lower respiratory tract aspirates. | Diagnostic test | Case, Matched-Control |
| HR-CT-scanAlso: CT, CATHigh-resolution computer tomography, or CT/CAT, is an X-ray scan that produces images of the chest and is used as a confirmatory test in symptomatic patients that have a negative PCR test. | Radiation | Case |
Primary outcome
Digital vibroacoustic biomarker diagnostic performance characteristics
Time frame: Enrollment through to study completion (min 48hrs through to 3 months)
Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.
1 secondary outcome
imPulse™ Una infrasound-to-ultrasound e-stethoscope device safety
Time frame: Enrollment through to study completion (min 48hrs through to 3 months)
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 19 May 2022.
- SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ UnaLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and COVID-19 Pneumonia, run by Level 42 AI, Inc. at 3 sites in 3 countries.
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 3 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Democratic Republic of the Congo, India, Senegal. 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?
Digital vibroacoustic biomarker diagnostic performance characteristics (time frame: Enrollment through to study completion (min 48hrs through to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.