RiskSEARCH: Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

• Sponsor: Current Health (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04709068
• Collaborator: Biomedical Advanced Research and Development Authority (U.S. Fed)
• Enrollment: 8
• Location: 1
• Actual Duration (Months): 3.7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Device: Current Health

Study Design

• Study Type: Observational
• Actual Enrollment: 8 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization
• Actual Study Start Date: Feb 8, 2021
• Actual Primary Completion Date: May 3, 2021
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Other Outcome Measures

1. Death [up to 30 days]

   Digital biomarker-based algorithm that predicts likelihood of death.

2. ICU Admission [up to 30 days]

   Digital biomarker-based algorithm that predicts likelihood of being admitted to the ICU for either non-invasive, invasive ventilation or vasopressor support.

3. Recovery [up to 30 days]

   Digital biomarker-based algorithm that predicts likelihood of recovery from COVID-19.

4. Hospitalization [up to 30 days]

   Digital biomarker-based algorithm that predicts likelihood of requiring hospitalization of at least 24 hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Current Health	New York	New York	United States	10017

Sponsors and Collaborators

• Current Health
• Biomedical Advanced Research and Development Authority

Investigators

• Principal Investigator: Adam Wolfberg, MD, Current Health

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 11, 2021

More Information

Publications

None provided.

• Responsible Party: Current Health
• ClinicalTrials.gov Identifier: NCT04709068
• Other Study ID Numbers: Pro00047371
• First Posted: Jan 14, 2021
• Last Update Posted: Aug 19, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Current Health: wearable; at-home
• Additional relevant MeSH terms: COVID-19

Study Results

Participant Flow

Arm/Group Title	COVID19+
Arm/Group Description	Current Health: wearable device and tablet used to collect health measures at home
Period Title: Overall Study
STARTED	8
COMPLETED	8
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	COVID19+
Arm/Group Description	Current Health: wearable device and tablet used to collect health measures at home
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.6 (10)
Sex: Female, Male (Count of Participants)
Female	6 75%
Male	2 25%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 12.5%
White	7 87.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	8 100%

Outcome Measures

1. Primary Outcome

Title	Participant Compliance
Description	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.
Time Frame	up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	COVID19+
Arm/Group Description	Current Health: wearable device and tablet used to collect health measures at home
Measure Participants	8
Median (Inter-Quartile Range) [percentage of time]	74

2. Other Pre-specified Outcome

Title	Death
Description	Digital biomarker-based algorithm that predicts likelihood of death.
Time Frame	up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Other Pre-specified Outcome

Title	ICU Admission
Description	Digital biomarker-based algorithm that predicts likelihood of being admitted to the ICU for either non-invasive, invasive ventilation or vasopressor support.
Time Frame	up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	Recovery
Description	Digital biomarker-based algorithm that predicts likelihood of recovery from COVID-19.
Time Frame	up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

Title	Hospitalization
Description	Digital biomarker-based algorithm that predicts likelihood of requiring hospitalization of at least 24 hours.
Time Frame	up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	30 days
Arm/Group Title	COVID19+
Arm/Group Description	Current Health: wearable device and tablet used to collect health measures at home
All Cause Mortality
	COVID19+
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	COVID19+
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	COVID19+
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.