Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness

AudibleHealth AI, Inc.1,126 enrolled

Overview

The AudibleHealth Dx is a diagnostic software as a medical device (Dx SaMD) consisting of an ensemble of software subroutines that interacts with a proprietary database of Signal Data Signatures (SDS), using Artificial Intelligence/Machine Learning (AI/ML) to analyze forced cough vocalization signal data signatures (FCV-SDS) for diagnostic purposes. This study will evaluate the performance of the AudibleHealth Dx in comparison to a standard of care Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test for the diagnosis of COVID-19. Bidirectional Sanger sequencing will be used to reduce the rate of false negative and false positive results. A secondary purpose of the study will be usability testing of the device for participants and providers.

The study is a prospective, multi-site, non-inferiority trial comparing the AudibleHealth Dx to Emergency Use Authorization (EUA) approved COVID-19 RT-PCR testing to demonstrate non-inferiority of the PPA and NPA when using this device to diagnose COVID-19 illness. The AudibleHealth Dx test, the "Xpert Xpress SARS-CoV-2 RT-PCR" (brand name) test, and bidirectional Sanger sequencing will be performed for each participant during a single encounter. Participants and staff will be blinded to AudibleHealth Dx results and the RT-PCR status at the time of testing. No one will know both results in real-time except for the Site Coordinators and unblinded statistician specifically authorized to have these results for enrollment, audit, data tracking, and data compiling purposes. Unblinding of the results will occur after the AudibleHealth Dx, RT-PCR, and variant sequencing results have been obtained. Results for the RT-PCR test will be received by the participant according to the clinical site's protocol. Variant sequencing results will be handled by each site according to their protocol. Target enrollment for this trial will be 65 COVID-19 positive cases and 247 COVID-19 negative cases, presuming a prevalence of 0.17 for a total of 312 subjects meeting all inclusion criteria.

Study Type

OBSERVATIONAL

Enrollment

1,126

Conditions

COVID19

Interventions

Diagnostic Software as Medical DeviceDIAGNOSTIC_TEST

AudibleHealth Dx is an investigational Dx SaMD consisting of an ensemble of software subroutines that interacts with a proprietary database of signal data signatures (SDS) using Artificial Intelligence/Machine Learning (AI/ML) to analyze forced cough vocalization signal data signatures (FCV-SDS) for diagnostic purposes. The intended use for the AudibleHealth Dx AI/ML-based Dx SaMD using FCV-SDS is for the diagnosis of acute and chronic illnesses. The AudibleHealth Dx is a cloud-based AI/ML (locked ML) diagnostic software as medical device (Dx SaMD) with a mobile app based graphical user interface (GUI) designed to operate with COTS Android Operating System (OS) and Apple OS based mobile devices. The AudibleHealth Dx system uses a forced cough vocalization (FCV) signal data signature (SDS) to diagnose COVID-19 illness in ambulatory adults. Results are sent to ordering physicians, State Health Departments, and participants using Health Level 7 (HL7) compliant communication protocols.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or Female, 18 years of age or older * Present for elective, outpatient COVID-19 RT-PCR testing * Meet the FDA EUA approved indications for use for the RT-PCR nasal swab test for COVID-19 * Stated willingness to comply with all trial procedures and availability for the duration of the trial * Informed consent must be obtained prior to testing Exclusion Criteria: * Less than 18 years of age * Unable to cough voluntarily * Present with acute traumatic injury to the head, neck, throat, chest, abdomen or trunk * Patent tracheostomy stoma * Recent chest/abdomen/trunk trauma or surgery, recent/persistent neurovascular injury or recent intracranial surgery * Medical history of cribriform plate injury or cribriform plate surgery, diaphragmatic hernia, external beam neck/throat/maxillofacial radiation, phrenic nerve injury/palsy, radical neck/throat/maxillofacial surgery, vocal cord trauma or nodules * Since persons with aphasia may have difficulty in producing an FCV-SDS in the time allotted by the app, this population also will be excluded from the current trial

Outcomes

Primary Outcomes

Non-inferiority of the positive percent agreement (PPA)

To demonstrate non-inferiority of the positive percent agreement (PPA) of the AudibleHealth Dx when compared to EUA approved COVID-19 RT-PCR testing (specifically the Xpert Xpress SARS-CoV-2 RT-PCR test for the diagnosis of COVID-19 illness.)

Time frame: Participants will have a single encounter lasting less than one hour; anticipated study duration is 6 weeks. Target enrollment is 65 positive and 247 negative participants. (Interim analysis will be conducted at the halfway point.)

Non-inferiority of the negative percent agreement (NPA)

To demonstrate non-inferiority of the negative percent agreement (NPA) of the AudibleHealth Dx when compared to EUA approved COVID-19 RT-PCR testing (specifically the Xpert Xpress SARS-CoV-2 RT-PCR test for the diagnosis of COVID-19 illness.)