CompletedNot Applicable

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

United States1,126 participantsStarted 2022-01-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.)

Non-inferiority of the negative percent agreement (NPA)

Trial details

NCT IDNCT05175690

SponsorAudibleHealth AI, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-05-03

View on ClinicalTrials.gov More COVID19 trials