Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization (RiskSEARCH)

The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Device: Current Health

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Current Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

Inclusion Criteria:

• Living in the United States (contiguous states)
• Aged 21 years or older
• Able to provide documentation of +PCR or +antigen test for COVID-19 within the past 48 hours
• Self-reports that comfortable and willing to wear the wearable device and interact with a tablet-based interface daily
• Able to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow up.

Exclusion Criteria:

• Under the age of 21
• Received a positive test result more than 48 hours prior to contacting study staff or has a pending test for COVID-19
• Cannot confirm a PCR or antigen positive test for COVID-19
• Is unable to read English
• Is unwilling to wear the device 24 hours/day except for showering/bathing or interact with a tablet-based interface for daily questionnaire
• Is unwilling or unable to provide baseline data required for entry into the study
• Is unable to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow-up
• Heavy tattooing on both upper arms
• Known atrial fibrillation (permanent or paroxysmal)
• Has taken/is taking part in a COVID-19 vaccine or treatment trial

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID19+	Device: Current Health; wearable device and tablet used to collect health measures at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Compliance	a percentage of the number of 15 minute windows with vital sign data compared to the number of 15 minute windows with the potential to have vital sign data. The 15 minute windows with the potential to have vital sign data was calculated based on the number of days the participant was enrolled in the study. There were multiple study endpoints; the number of days varied between 14-30 days.	up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Digital biomarker-based algorithm that predicts likelihood of death.	up to 30 days
ICU Admission	Digital biomarker-based algorithm that predicts likelihood of being admitted to the ICU for either non-invasive, invasive ventilation or vasopressor support.	up to 30 days
Recovery	Digital biomarker-based algorithm that predicts likelihood of recovery from COVID-19.	up to 30 days
Hospitalization	Digital biomarker-based algorithm that predicts likelihood of requiring hospitalization of at least 24 hours.	up to 30 days

Collaborators and Investigators

• Sponsor: Current Health
• Collaborators: Biomedical Advanced Research and Development Authority
• Investigators: Principal Investigator: Adam Wolfberg, MD, Current Health

Publications and helpful links

Helpful Links

• study information and eligibility for enrollment

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: wearable; at-home
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00047371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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