Clinical trial NCT05175690: Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19
Keywords: 2019 Novel Coronavirus Disease
2019 Novel Coronavirus Infection
2019-nCoV Disease
2019-nCoV Infection
COVID-19 Pandemic
COVID-19 Pandemics
COVID-19 Virus Disease
COVID-19 Virus Infection
Coronavirus Disease 2019
Coronavirus Disease-19
SARS Coronavirus 2 Infection
SARS-CoV-2 Infection
Severe Acute Respiratory Syndrome Coronavirus 2 Infection
SARS-CoV-2
Software as Medical Device
Diagnostic Software as Medical Device
SaMD
Dx SaMD
Forced Cough Vocalization
Signal Data Signature
FCV
SDS
FCV-SDS
Delta
Omicron
Artificial Intelligence
Machine Learning
AI
ML
AI/ML
Classifier
Convolutional Neural Network
CNN
Recurrent Neural Network
RNN
Oracle
Ensemble
Lead sponsor: AudibleHealth AI, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of South Florida
name: R. P. Chiacchierini Consulting, LLC
name: Analytical Solutions Group, Inc.
name: Renaissance Worldwide Solutions, LLC
name: Medical & Regulatory Affairs Specialists, LLC
First posted: 2022-01-04
Enrollment: 1126
Sex: ALL
Minimum age (years): 18
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. 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.

Detailed description: 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.

Eligibility criteria: 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

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 247 negative participants. (Interim analysis will be conducted at the halfway point.)
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 247 negative participants. (Interim analysis will be conducted at the halfway point.)
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: RAIsonance, Inc.
name: Karl Kelley, MD
role: PRINCIPAL_INVESTIGATOR
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