Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

NCT04709068 | Terminated Results FDA Device

• 1 other identifier: Pro00047371
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

wearable; at-home

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

COVID19+

Device: Current Health

Interventions

Current Health DEVICE

wearable device and tablet used to collect health measures at home

COVID19+

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Current Health: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Current Health

New York, New York, 10017, United States

Location

Related Links

• study information and eligibility for enrollment

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Research Lead
• Organization: Current Health

study.team@currenthealth.com

617-208-4239

Study Officials

• Adam Wolfberg, MD

  Current Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: February 8, 2021
• Primary Completion: May 3, 2021
• Study Completion: June 1, 2021
• Last Updated: September 19, 2024
• Results First Posted: August 19, 2021

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)