Status:
WITHDRAWN
AIDI - Research & Development of a Multisensor-Based Machine Learning Technology for Real-Time Automated Detection of COVID-19 Decompensation
Lead Sponsor:
AIDAR Health, Inc.
Collaborating Sponsors:
Avania
Conditions:
Sars-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 S...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05220306
Start Date
January 27 2022
End Date
July 31 2022
Last Update
February 8 2023
Active Locations (1)
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1
Maxis Llc
San Jose, California, United States, 95120