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

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).

Study Overview

• Status: Withdrawn
• Conditions: Sars-CoV-2 Infection
• Intervention / Treatment: Device: Monitoring of vital signs

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95120
      • Maxis Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device Arm; Participants will use the MouthLab device for monitoring their vital signs	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AIDAR Health, Inc.
• Collaborators: MAXIS, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 27, 2022
• Primary Completion (ACTUAL): July 31, 2022
• Study Completion (ANTICIPATED): July 31, 2022

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (ACTUAL): February 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ADR04-AIDI-C-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No