Clinical trial NCT04941209: imPulse™ Una Infrasound-to-ultrasound E-stethoscope
Official title: imPulse™ Una Infrasound-to-ultrasound E-stethoscope 2-minute to Result COVID-19 Self-directed & Point-of-care Screening Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
COVID-19 Pneumonia
COVID-19 Respiratory Infection
COVID-19 Acute Respiratory Distress Syndrome
Mass Screening
Corona Virus Infection
Vaccine Virus Shedding
Keywords: infrasound
ultrasound
vibroacoustics
vibrome
digital-biosignature
e-stethoscope
Lead sponsor: Level 42 AI, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Asian Institute of Public Health
name: Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation (IRESSEF)
name: Laboratoire de la foundation Gombes
First posted: 2021-06-28
Enrollment: 702
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Digital vibroacoustic biomarker diagnostic performance characteristics
timeFrame: Enrollment through to study completion (min 48hrs through to 3 months)
Secondary outcomes:
measure: imPulse™ Una infrasound-to-ultrasound e-stethoscope device safety
timeFrame: Enrollment through to study completion (min 48hrs through to 3 months)
Other outcomes:
Locations:
city: Pointe Noire
country: Congo, The Democratic Republic of the
facility: Laboratoire de la foundation Gombes
state: Kouilou
city: Bhubaneswar
country: India
facility: Asian Institute of Public Health
state: Odisha
city: Dakar
country: Senegal
facility: Institute for Health Research, Epidemiological Surveillance and Training ( IRESSEF)
state: Almadies
Study officials:
References: