Detection of COVID-19 Decompensation

physIQ, Inc.1,000 enrolled

Overview

In this study we will be monitoring for patient events (emergency department admission, hospital admission, admission to an observation unit, or death) and evaluating the feasibility and utility of using pinpointIQ in the management of patients with COVID-19. Vital sign (physiology data) is collected to build a Covid Decompensation Index and contribute data to a Covid Digital Hub supported by the National Institutes of Health.

This is a prospective, non-randomized, open-label, two-phase design. The primary focus for the study is data collection for index development. This will be done in two phases: the first phase allows for determination of predictor variables that establish the COVID-19 Decompensation Index (CDI) and the second phase establishes performance of the CDI. A participant is considered to have completed the study if he or she completes all phases of the study including the last day of monitoring (day 28).

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Covid19

Interventions

Use of the pinpointIQ solution (physIQ, Inc.)DEVICE

Patients are monitored for 28 days post COVID19 diagnosis or COVID19 post-hospitalization discharge using the pinpointIQ solution.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Obtained signed and dated informed consent form Patient in the University of Illinois Health System Patient agrees to comply with all study procedures and availability for the duration of the study Male or female, aged \> 18 years of age Patient diagnosed with COVID-19 (positive SARS CoV2 test) Patient agrees to refrain from swimming or taking baths (any activity that submerges the biosensor in water for any period). Showering is okay. Exclusion Criteria: Known allergic reactions to components of the hydrocolloid gel adhesives Subject has cognitive or physical limitations that, in the opinion of the investigator, limits the subject's ability to fully follow study procedures Cognitive ability, in the opinion of the investigator, that limits the patient's ability to use the biosensor and smartphone consistent with study requirements. Does not speak or read English or Spanish

Locations (4)

Rush University Medical Center

Chicago, Illinois, United States

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

University of Texas Health

Houston, Texas, United States

Outcomes

Primary Outcomes

Development of Covid Decompensation Index

To collect sufficient data to identify a set of predictor variables that most accurately predict a COVID-19 decompensation event aimed at developing and validating a clinically useful COVID Decompensation Index (CDI).

Time frame: 4 months

Secondary Outcomes

Feasibility

To evaluate the feasibility of using the pinpointIQ solution as a tool for healthcare professionals to identify physiologic decompensation and manage the study populations based on physIQ validated rule sets and analytics.

Time frame: 4 months

Data from ClinicalTrials.gov

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