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

Aidar Health

Status

Withdrawn

Conditions

Sars-CoV-2 Infection

Treatments

Device: Monitoring of vital signs

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05220306

ADR04-AIDI-C-21

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.