imPulse™ Una Infrasound-to-ultrasound E-stethoscope

Sponsor

Level 42 AI, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04941209

Collaborator

Asian Institute of Public Health (Other), Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation (IRESSEF) (Other), Laboratoire de la foundation Gombes (Other)

702

Enrollment

Locations

8.6

Actual Duration (Months)

234

Patients Per Site

27.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 child mass screening.

Condition or Disease	Intervention/Treatment	Phase
Covid19 COVID-19 Pneumonia COVID-19 Respiratory Infection COVID-19 Acute Respiratory Distress Syndrome Mass Screening Corona Virus Infection Vaccine Virus Shedding	Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope Diagnostic Test: (PPA >95%) FDA EUA RT-PCR Radiation: HR-CT-scan

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

Study Type:

Observational

Actual Enrollment :

702 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

imPulse™ Una Infrasound-to-ultrasound E-stethoscope 2-minute to Result COVID-19 Self-directed & Point-of-care Screening Test

Actual Study Start Date :

Jun 11, 2021

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Case Inpatients/Outpatients with confirmed COVID-19 with and without pulmonary symptoms.	Device: imPulse™ Una infrasound-to-ultrasound 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. Diagnostic Test: (PPA >95%) FDA EUA 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. Other Names: RT-PCR Radiation: HR-CT-scan 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. Other Names: CT CAT
Matched-Control Outpatients without COVID-19 without known non-pulmonary diagnoses or symptoms.	Device: imPulse™ Una infrasound-to-ultrasound 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. Diagnostic Test: (PPA >95%) FDA EUA 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. Other Names: RT-PCR

Arm

Intervention/Treatment

Case

Inpatients/Outpatients with confirmed COVID-19 with and without pulmonary symptoms.

Device: imPulse™ Una infrasound-to-ultrasound 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.

Diagnostic Test: (PPA >95%) FDA EUA 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.

Other Names:

RT-PCR

Radiation: HR-CT-scan

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.

Other Names:

CAT

Matched-Control

Outpatients without COVID-19 without known non-pulmonary diagnoses or symptoms.

Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope

Diagnostic Test: (PPA >95%) FDA EUA RT-PCR

Other Names:

RT-PCR

Outcome Measures

Primary Outcome Measures

Digital vibroacoustic biomarker diagnostic performance characteristics [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.

Secondary Outcome Measures

imPulse™ Una infrasound-to-ultrasound e-stethoscope device safety [Enrollment through to study completion (min 48hrs through to 3 months)]
Device safety

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratoire de la foundation Gombes	Pointe Noire	Kouilou	Congo, The Democratic Republic of the
2	Asian Institute of Public Health	Bhubaneswar	Odisha	India	751002
3	Institute for Health Research, Epidemiological Surveillance and Training ( IRESSEF)	Dakar	Almadies	Senegal

Sponsors and Collaborators

Level 42 AI, Inc.
Asian Institute of Public Health
Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation (IRESSEF)
Laboratoire de la foundation Gombes