Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

Terminated

• Conditions: Covid19
• Interventions: Device: Current Health

• Registration Number: NCT04709068
• Lead Sponsor: Current Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Study Start: 2021-02-08
• Primary Completion: 2021-05-03
• Study Completion: 2021-06-01
• Status Verified: 2021-08
• Results First Submitted: 2021-08-09
• Results First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Results First Posted: 2021-08-19
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID19+	Current Health	-

Primary Outcome Measures

Name	Time	Method
Participant Compliance	up to 30 days	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.

Trial Locations

Locations (1)

Current Health; 🇺🇸 New York, New York, United States