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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-27

Study Completion Date

2022-07-31

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).

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Detailed Description

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Conditions

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Sars-CoV-2 Infection

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Device Arm

Participants will use the MouthLab device for monitoring their vital signs

Group Type EXPERIMENTAL

Monitoring of vital signs

Intervention Type DEVICE

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.

Interventions

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Monitoring of vital signs

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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No