Trial Outcomes & Findings for Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization (NCT NCT04709068)

NCT ID: NCT04709068

Last Updated: 2024-09-19

Results Overview

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.

• Recruitment status: TERMINATED
• Target enrollment: 8 participants
• Primary outcome timeframe: up to 30 days
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	COVID19+ Current Health: wearable device and tablet used to collect health measures at home
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

Baseline characteristics by cohort

Measure	COVID19+ n=8 Participants Current Health: wearable device and tablet used to collect health measures at home
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35.6 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	COVID19+ n=8 Participants Current Health: wearable device and tablet used to collect health measures at home
Participant Compliance	74 percentage of time Interval 60.0 to 83.0

Adverse Events

COVID19+

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Lead

Current Health

Phone: 617-208-4239

Email: study.team@currenthealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place