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

Sars-CoV-2 Infection Clinical Trial

— AIDI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05220306
• Other study ID #: ADR04-AIDI-C-21
• Status: Withdrawn
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2022
• Source: AIDAR Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV-2 Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Maxis Llc	San Jose	California

Sponsors (2)

Lead Sponsor	Collaborator
AIDAR Health, Inc.	MAXIS, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Usability of MouthLab device	Usability of the MouthLab device will be assessed via a questionnaire at study exit	At 60 days
Secondary	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