Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

Covid19 Clinical Trial

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Official title:

Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04709068
• Other study ID #: Pro00047371
• Status: Terminated
• Start date: February 8, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2021
• Source: Current Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 1, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Device:
• Current Health
wearable device and tablet used to collect health measures at home

Locations

Country	Name	City	State
United States	Current Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Current Health	Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death	Digital biomarker-based algorithm that predicts likelihood of death.	up to 30 days
Other	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
Other	Recovery	Digital biomarker-based algorithm that predicts likelihood of recovery from COVID-19.	up to 30 days
Other	Hospitalization	Digital biomarker-based algorithm that predicts likelihood of requiring hospitalization of at least 24 hours.	up to 30 days
Primary	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

External Links

•   study information and eligibility for enrollment