imPulse™ Una Infrasound-to-ultrasound E-stethoscope

Completed

• Conditions: COVID-19 Acute Respiratory Distress Syndrome; Vaccine Virus Shedding; COVID-19 Pneumonia; Mass Screening; Covid19; COVID-19 Respiratory Infection; Corona Virus Infection
• Interventions: Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope; Diagnostic Test: (PPA >95%) FDA EUA RT-PCR; Radiation: HR-CT-scan

• Registration Number: NCT04941209
• Lead Sponsor: Level 42 AI, Inc.

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.

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 Timeline

• Study Start: 2021-06-11
• Study First Submitted: 2021-06-20
• Study First Submitted QC: 2021-06-20
• Study First Posted: 2021-06-28
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 702

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	imPulse™ Una infrasound-to-ultrasound e-stethoscope	Inpatients/Outpatients with confirmed COVID-19 with and without pulmonary symptoms.
Case	(PPA >95%) FDA EUA RT-PCR	Inpatients/Outpatients with confirmed COVID-19 with and without pulmonary symptoms.
Matched-Control	(PPA >95%) FDA EUA RT-PCR	Outpatients without COVID-19 without known non-pulmonary diagnoses or symptoms.
Case	HR-CT-scan	Inpatients/Outpatients with confirmed COVID-19 with and without pulmonary symptoms.
Matched-Control	imPulse™ Una infrasound-to-ultrasound e-stethoscope	Outpatients without COVID-19 without known non-pulmonary diagnoses or symptoms.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (3)

Institute for Health Research, Epidemiological Surveillance and Training ( IRESSEF); 🇸🇳 Dakar, Almadies, Senegal

Laboratoire de la foundation Gombes; 🇨🇩 Pointe Noire, Kouilou, Congo, The Democratic Republic of the

Asian Institute of Public Health; 🇮🇳 Bhubaneswar, Odisha, India