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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
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.
Maxis Llc
San Jose, California, United States
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)
Time frame: 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)
Time frame: Daily for 60 days
Usability of MouthLab device
Usability of the MouthLab device will be assessed via a questionnaire at study exit
Time frame: 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
Time frame: Day 0 to Day 60
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