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).
Device: Use of the pinpointIQ solution (physIQ, Inc.)
Patients are monitored for 28 days post COVID19 diagnosis or COVID19 post-hospitalization discharge using the pinpointIQ solution.
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
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
Karen Larimer, PhD, Principal Investigator
physIQ, Inc.