WithdrawnNot Applicable

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

Stopped: No eligible patients could be found and funding was lost

United States0Started 2022-01-27

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Collect trends in physiological vital signs and symptom burden to identify individuals who are at risk of clinical decompensation

Timeframe: Daily for 60 days

AIDI evaluation

Timeframe: Daily for 60 days

Trial details

NCT IDNCT05220306

SponsorAIDAR Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-31

View on ClinicalTrials.gov More Sars-CoV-2 Infection trials