Detection of COVID-19 Decompensation (DeCODe)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04575532 |
Recruitment Status :
Enrolling by invitation
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Covid19 | Device: Use of the pinpointIQ solution (physIQ, Inc.) |
Study Type : | Observational |
Estimated Enrollment : | 400 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Personalized Analytics and Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation |
Estimated Study Start Date : | October 5, 2020 |
Estimated Primary Completion Date : | January 15, 2021 |
Estimated Study Completion Date : | January 22, 2021 |
- 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.
- 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).
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575532
United States, Illinois | |
University of Illinois Hospital and Health Sciences System | |
Chicago, Illinois, United States, 60612 |
Principal Investigator: | Karen Larimer, PhD | physIQ, Inc. |
Responsible Party: | physIQ, Inc. |
ClinicalTrials.gov Identifier: | NCT04575532 |
Other Study ID Numbers: |
CTP-004 |
First Posted: | October 5, 2020 Key Record Dates |
Last Update Posted: | October 5, 2020 |
Last Verified: | October 2020 |
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 |