AIDI - Research & Development of a Multisensor-Based Machine Learning Technology for Real-Time Automated Detection of COVID-19 Decompensation

Study Overview
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Brief Summary
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The AIDI study has to phases. It's purpose is to capture vital signs using a non-invasive, hand-held, home monitoring device (MouthLab Device) from individuals with COVID-19 or who test positive for SARS-CoV-2 (Phase I) and use an algorithm-based approach to identify individuals at risk of clinical decompensation (Phase II). Up to 500 unvaccinated and partially vaccinated subjects will be included (up to 100 in Phase I and up to 400 in Phase II).

Official Title
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AIDI - Research & Development of a Multisensor-Based Machine Learning Technology for Real-Time Automated Detection of COVID-19 Decompensation

Conditions
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Sars-CoV-2 Infection

Intervention / Treatment
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* Device: Monitoring of vital signs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older Unvaccinated individuals, or individuals who have received only 1 dose of an mRNA vaccine Individuals who have received a positive SARS-CoV-2 result within 24-48 hours (lab-based PCR or antigen test) Willing and able to provide informed consent Ability to read, write, and comprehend English Have no functional limitation that would impede the use of the MouthLab device Willing to provide access to health information via electronic health records (EHR) Exclusion Criteria: Currently receiving hospice care Have a left ventricular assist device Left-sided hemiplegia or any other motor deficits that may restrict the use of the device. individuals with cognitive deficits that impede their ability to comprehend and give informed consent. Individuals who are enrolled in any other investigational research studies of SARS-CoV2 or COVID-19 Individuals who are treated with monoclonal antibody therapy prior to diagnosis Individuals who are admitted to a hospital or acute care facility at the time of diagnosis Individuals with pacemakers or implanted cardio-defibrillators (ICDs) History of hemoptysis, pneumothorax, thoracic or abdominal aneurysm, pulmonary embolism, or stroke History of unstable cardiovascular status, including recent myocardial infarction (MI within 30 days), unstable angina, or uncontrolled hypertension Color blindness Chest, abdominal or eye surgery within the preceding 14 days Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional Model Description: Phase I/Derivation Cohort (100 patients): This phase will use the MouthLab to capture vital signs. This data will help create Aidar's algorithm-based decompensation index (AIDI) that utilizes changes in vital signs to identify individuals who test positive for SARS-CoV-2 or with COVID-19 infection and are at risk of developing clinical decompensation. Phase II/Validation Cohort (400 patients): This phase will use the MouthLab to capture vital signs and use Aidar's algorithm-based decompensation index (AIDI) to identify individuals at risk of clinical decompensation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Arm<br>Participants will use the MouthLab device for monitoring their vital signs | Device: Monitoring of vital signs<br>* The MouthLab is a hand-held device. The user holds the unit in their left hand with the Mouthpiece between the teeth and lips and breathes normally into the device for 30 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect trends in physiological vital signs and symptom burden to identify individuals who are at risk of clinical decompensation | Accurately collect trends in physiological vital signs and symptom burden of individuals with COVID-19 infection or who test positive for SARS-CoV-2 captured with the MouthLab to identify individuals who are at risk of clinical decompensation. (Phase 1) | Daily for 60 days | 
| AIDI evaluation | Evaluate trends in physiological vital signs and symptom burden of individuals with COVID-19 infection or who test positive for SARS-CoV-2 which are captured with the MouthLab device to evaluate the ability of the Aidar COVID-19 Decompensation Index (AIDI) to accurately identify individuals at risk of clinical decompensation. (Phase 2) | Daily for 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of MouthLab device | Usability of the MouthLab device will be assessed via a questionnaire at study exit | At 60 days | 
| Evaluate any short-term changes in vital signs among patients with underlying comorbid conditions | Evaluate any short-term changes in vital signs among patients with underlying comorbid conditions | Day 0 to Day 60 |