Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

NCT ID: NCT04709068

Last Updated: 2024-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-08

Study Completion Date

2021-06-01

Brief Summary

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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

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID19+

Current Health

Intervention Type DEVICE

wearable device and tablet used to collect health measures at home

Interventions

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Current Health

wearable device and tablet used to collect health measures at home

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Living in the United States (contiguous states)
* Aged 21 years or older
* Able to provide documentation of +Polymerase Chain Reaction (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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomedical Advanced Research and Development Authority

FED

Sponsor Role collaborator

Current Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Wolfberg, MD

Role: PRINCIPAL_INVESTIGATOR

Current Health

Locations

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Current Health

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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https://community.currenthealth.com/covid19-study

study information and eligibility for enrollment

Other Identifiers

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Pro00047371

Identifier Type: -

Identifier Source: org_study_id

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