Detection of COVID-19 Decompensation

Covid19 Clinical Trial

— DeCODe  

Official title:

Personalized Analytics and Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04575532
• Other study ID #: CTP-004
• Secondary ID: 75N91020C00040
• Status: Completed
• Start date: October 5, 2020
• Est. completion date: September 9, 2021

Study information

• Verified date: May 2021
• Source: physIQ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 months
Secondary	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.	4 months

External Links

•   Sponsor's website