imPulse™ Una Infrasound-to-ultrasound E-stethoscope

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941209
• Other study ID #: L42AI-20210003
• Status: Completed
• Start date: June 11, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: Level 42 AI, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 child mass screening.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• COVID-19 Pneumonia
• Covid19
• Infections
• Mass Screening
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Tract Infections
• Vaccine Virus Shedding

Intervention

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.

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.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
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

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  India,  Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Enrollment through to study completion (min 48hrs through to 3 months)
Secondary	imPulse™ Una infrasound-to-ultrasound e-stethoscope device safety	Device safety	Enrollment through to study completion (min 48hrs through to 3 months)

External Links

•   SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ Una