Detection of COVID-19 Decompensation (DeCODe)

• ClinicalTrials.gov Identifier: NCT04575532
• Recruitment Status: Completed
• First Posted: October 5, 2020
• Last Update Posted: September 13, 2021
• Sponsor: physIQ, Inc.
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB); National Cancer Institute (NCI); University of Illinois at Chicago
• Information provided by (Responsible Party): physIQ, Inc.

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
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: October 5, 2020
• Actual Primary Completion Date: September 9, 2021
• Actual Study Completion Date: September 9, 2021

Groups and Cohorts

Intervention Details:

• 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.

Outcome Measures

Primary Outcome Measures :

1. Development of Covid Decompensation Index [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Participants will be adult patients in the University of Illinois Health System (UIH). Participants will be recruited from two pools of patients at UIH: 1) patients tested in the outpatient setting who have a positive result for SAR-Co-V2 (COVID-19) and 2) patients who were admitted to the hospital with a diagnosis of COVID-19 and subsequently discharged to home convalescence. This will be a convenience sample. Phase 1 will have a sample size of 400 and Phase 2 will have a sample size of 1,200.

Criteria

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

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, United States, 60612

NorthShore University HealthSystem

Evanston, Illinois, United States, 60210

United States, Texas

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.

More Information

Additional Information:

Sponsor's website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Larimer K, Wegerich S, Splan J, Chestek D, Prendergast H, Vanden Hoek T. Personalized Analytics and a Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation (DeCODe): Protocol for the Development of the COVID-19 Decompensation Index. JMIR Res Protoc. 2021 May 26;10(5):e27271. doi: 10.2196/27271.

• Responsible Party: physIQ, Inc.
• ClinicalTrials.gov Identifier: NCT04575532
• Other Study ID Numbers: CTP-004; 75N91020C00040 ( Other Grant/Funding Number: NIH/NBIB/NCI )
• First Posted: October 5, 2020
• Last Update Posted: September 13, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: This effort is part of a hub-and-spoke technology implementation model created by the NIH, in which each supported digital health solution (the spokes) will be required to share deidentified data and other digital assets it generates with an NIH-supported central data hub. The data hub will provide global researchers a single access point to deidentified data, algorithms, and other capabilities generated by the various digital health solutions. Standards that enhance interoperability will enable unambiguous linking of digital resources among the spokes of the hub. This will enable researchers, for example, to apply the CDI developed in this project's spoke to individuals' health data that was collected by other spokes.
• Supporting Materials: Analytic Code
• Time Frame: January 2021
• Access Criteria: NIH is gate keeper of data access through the digital hub

• 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; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases