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
Verified date | May 2022 |
Source | Level 42 AI, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 702 |
Est. completion date | February 28, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | |
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 |
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 |
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 |
Congo, The Democratic Republic of the, India, Senegal,
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) |
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