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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- Non-inferiority of the negative percent agreement (NPA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Non-inferiority of the negative percent agreement (NPA)
时间窗: 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.
2. To demonstrate non-inferiority of the negative percent agreement (NPA) of the AudibleHealth Dx when compared to FDA approved SARS-CoV-2 RT-PCR testing for the diagnosis of COVID-19 illness.
Non-inferiority of the positive percent agreement (PPA)
时间窗: 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.
To demonstrate non-inferiority of the positive percent agreement (PPA) of the AudibleHealth Dx when compared to FDA approved SARS CoV-2 RT-PCR testing for the diagnosis of COVID-19 illness
次要结局
未报告次要终点