DeCODe: Detection of COVID-19 Decompensation

• Sponsor: physIQ, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04575532
• Collaborator: National Institute for Biomedical Imaging and Bioengineering (NIBIB) (NIH), National Cancer Institute (NCI) (NIH), University of Illinois at Chicago (Other)
• Enrollment: 1,000
• Locations: 4
• Actual Duration (Months): 11.1
• Patients Per Site: 250
• Patients Per Site Per Month: 22.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Device: Use of the pinpointIQ solution (physIQ, Inc.)

Detailed Description

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 Design

• Study Type: Observational
• Actual Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Personalized Analytics and Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation
• Actual Study Start Date: Oct 5, 2020
• Actual Primary Completion Date: Sep 9, 2021
• Actual Study Completion Date: Sep 9, 2021

Outcome Measures

Primary Outcome Measures

1. Development of Covid Decompensation Index [4 months]

   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).

Secondary Outcome Measures

1. Feasibility [4 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612
2	University of Illinois Hospital and Health Sciences System	Chicago	Illinois	United States	60612
3	NorthShore University HealthSystem	Evanston	Illinois	United States	60210
4	University of Texas Health	Houston	Texas	United States	77004

Sponsors and Collaborators

• physIQ, Inc.
• National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• National Cancer Institute (NCI)
• University of Illinois at Chicago

Investigators

• Principal Investigator: Karen Larimer, PhD, physIQ, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor's website

Publications

None provided.

• Responsible Party: physIQ, Inc.
• ClinicalTrials.gov Identifier: NCT04575532
• Other Study ID Numbers: CTP-004; 75N91020C00040
• First Posted: Oct 5, 2020
• Last Update Posted: Sep 13, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Sep 13, 2021