Evaluation of the Artificial Intelligence/Machine Learning-Based Diagnostic Software as a Medical Device Using Forced Cough Vocalization Signal Data Signatures in the Diagnosis of COVID-19 Illness: A Prospective, Two-Arm Non-Inferiority Clinical Validation Trial of AudibleHealth Dx Software as a Medical Device (EUA-US)
Trial ID: NCT05364268
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2022-05-04
Completion date: 2022-06-01
Sponsor: AudibleHealth AI, Inc.
Collaborators: Sunrise Research Institute; Analytic Solutions Group; Kelley Medical Consultants LLC; R. P. Chiacchierini Consulting, LLC
Conditions: 2019 Novel Coronavirus Disease; 2019 Novel Coronavirus Infection; 2019-nCoV Disease; COVID-19 Pandemic; COVID-19 Virus Disease; COVID-19 Virus Infection; Coronavirus Disease 2019; Coronavirus Disease-19; SARS-CoV-2 Infection
Interventions: Diagnostic Test: Diagnostic Software as Medical Device
Locations: Sunrise Research Institute
Countries: United States
Enrollment: 514
Age range: 18 Years - 100 Years
Sex: ALL

Summary:
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.

A secondary purpose of the study will be usability testing of the device for participants and providers.

Eligibility criteria:
Inclusion Criteria:

* 18 years of age or older
* Present for elective, outpatient COVID-19 RT-PCR testing
* Meet the FDA EUA approved indications for use for RT-PCR nasal swab testing 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
* Ability to complete both the informed consent form and the screens on the medical device app in English (no translation to other languages is currently available)

Exclusion Criteria:

* Any individual who was a part of the AudibleHealth Dx Development, Training, and Usability trial (Training and test data sets are to be kept strictly separate.)
* Less than 18 years of age
* Unable to produce a voluntary forced cough vocalization (FCV)
* Recent 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:
Non-inferiority of the positive percent agreement (PPA); Non-inferiority of the negative percent agreement (NPA)