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

Not Applicable

Withdrawn

• Conditions: Sars-CoV-2 Infection
• Interventions: Device: Monitoring of vital signs

• Registration Number: NCT05220306
• Lead Sponsor: AIDAR Health, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-27
• Status Verified: 2022-02
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-02
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Device Arm	Monitoring of vital signs	Participants will use the MouthLab device for monitoring their vital signs

Primary Outcome Measures

Name	Time	Method
Collect trends in physiological vital signs and symptom burden to identify individuals who are at risk of clinical decompensation	Daily for 60 days	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)
AIDI evaluation	Daily for 60 days	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maxis Llc; 🇺🇸 San Jose, California, United States