Clinical trial NCT05364268: Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Keywords: Delta
Omicron
FCV-SDS
Artificial Intelligence
Signal Data Signature
Forced Cough Vocalization
Dx SaMD
SaMD
Diagnostic Software as Medical Device
Software as Medical Device
AI/ML
Lead sponsor: AudibleHealth AI, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sunrise Research Institute
name: Analytical Solutions Group, Inc.
name: Kelley Medical Consultants LLC
name: R. P. Chiacchierini Consulting, LLC
First posted: 2022-05-06
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults seeking elective, outpatient COVID RT-PCR testing will be included.

Brief 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.

Detailed description: The study is a prospective, multi-site, non-inferiority trial comparing the AudibleHealth Dx to FDA 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 and the "BioFire Respiratory 2.1 (RP2.1)" (brand name) test 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 the second RT-PCR results (if necessary for discordance) have been obtained. Results for the RT-PCR test will be received by the participant according to the clinical site's protocol.

Target enrollment for this trial will be 65 COVID-19 positive cases and 152 COVID-19 negative cases, presuming a prevalence of 0.30 for a total of 217 subjects meeting all inclusion criteria.

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

Primary outcomes:
measure: Non-inferiority of the positive percent agreement (PPA)
timeFrame: Participants will have a single encounter lasting less than one hour; anticipated study duration is 6 weeks. Target enrollment is 65 positive and 152 negative participants.
measure: Non-inferiority of the negative percent agreement (NPA)
timeFrame: Participants will have a single encounter lasting less than one hour; anticipated study duration is 6 weeks. Target enrollment is 65 positive and 152 negative participants.
Secondary outcomes:
Other outcomes:
Locations:
city: Sunrise
country: United States
facility: Sunrise Research Institute
state: Florida
Study officials:
affiliation: RAIsonance, Inc.
name: Karl Kelley, MD
role: PRINCIPAL_INVESTIGATOR
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