Clinical trial NCT04575532: Detection of COVID-19 Decompensation
Official title: Personalized Analytics and Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: physIQ, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: National Cancer Institute (NCI)
name: University of Illinois at Chicago
First posted: 2020-10-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility 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

Primary outcomes:
measure: Development of Covid Decompensation Index
timeFrame: 4 months
Secondary outcomes:
measure: Feasibility
timeFrame: 4 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Houston
country: United States
facility: University of Texas Health
state: Texas
Study officials:
affiliation: physIQ, Inc.
name: Karen Larimer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.