NCT04575532

Detection of COVID-19 Decompensation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: physIQ, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Covid19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-05
• Primary completion: 2021-09-09
• Completion: 2021-09-09
• First posted: 2020-10-05
• Last updated: 2021-09-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study