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Machine Learning Technology

Device Arm for COVID-19 (AIDI Trial)

N/A
Waitlist Available
Led By Sujith Shetty, MD
Research Sponsored by AIDAR Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female 18 years of age or older
Unvaccinated individuals, or individuals who have received only 1 dose of an mRNA vaccine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 60 days
Awards & highlights

AIDI 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).

Eligible Conditions
  • COVID-19

AIDI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

AIDI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AIDI evaluation
Collect trends in physiological vital signs and symptom burden to identify individuals who are at risk of clinical decompensation
Secondary outcome measures
Evaluate any short-term changes in vital signs among patients with underlying comorbid conditions
Usability of MouthLab device

AIDI Trial Design

1Treatment groups
Experimental Treatment
Group I: Device ArmExperimental Treatment1 Intervention
Participants will use the MouthLab device for monitoring their vital signs

Find a Location

Who is running the clinical trial?

AIDAR Health, Inc.Lead Sponsor
1 Previous Clinical Trials
204 Total Patients Enrolled
1 Trials studying COVID-19
204 Patients Enrolled for COVID-19
MAXIS, LLCUNKNOWN
1 Previous Clinical Trials
5 Total Patients Enrolled
Sujith Shetty, MDPrincipal InvestigatorMAXIS, LLC

Frequently Asked Questions

~0 spots leftby Mar 2025