A Virtual Prospective Study Exploring Activity Trackers and COVID-19 Infections

Sponsor

Evidation Health (Industry)

Overall Status

Completed

CT.gov ID

NCT04623138

Collaborator

Biomedical Advanced Research and Development Authority (U.S. Fed), Eli Lilly and Company (Industry), Bill and Melinda Gates Foundation (Other), Vir Biotechnology, Inc. (Industry), United States Department of Defense (U.S. Fed)

847

Enrollment

Location

6.9

Actual Duration (Months)

123.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, observational, exploratory study exploring the relationship between passively-collected data from wearable activity devices and SARS-CoV-2 infection

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV Infection

Study Design

Study Type:

Observational

Actual Enrollment :

847 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and SARS-CoV-2 Infection

Actual Study Start Date :

Nov 4, 2020

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Garmin Study Device Group Individuals who are randomly assigned to receive the Garmin vívosmart® 4
Empatica Study Device Group Individuals who are randomly assigned to receive the Empatica E4

Outcome Measures

Primary Outcome Measures

Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection [Through study completion, an average of 7 months]
To develop a database of physiological and behavioral data via wearable devices and self-reported questionnaires (e.g.,symptoms) combined with laboratory confirmation of SARS- CoV-2 infection.
Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data [Through study completion, an average of 7 months]
Physiological and behavioral data from wearable devices (Garmin vivosmart 4, Empatica E4) , patient self-reported data questionnaires (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and laboratory diagnostic confirmation of SARS-CoV-2 infection.

Secondary Outcome Measures

Lift of the analytical models as expressed as the ratio of COVID-19+ recall (COVID-19+ cases detected by model as a percentage of total positive cases)/Healthy false positives (healthy cases detected by the model as being COVID-19+). [Through study completion, an average of 7 months]
Lift is a measure of model performance and will be evaluated at multiple timepoints along the infection time-course (for example, 1 day prior to illness onset, onset, day 3, etc.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults 18+ years of age
Lives in the United States
Speaks, reads, and understands English
Willing and able to use and wear a wrist-worn activity device daily, during the day and during sleep, or as much as is possible, for the duration of the study
Meets minimum software and device requirements for the wrist-worn activity device (Apple iOS 12 and up, Android version 6.0 and up)
Willing to answer daily, weekly and monthly surveys for the duration of the study
Willing to provide weekly self-collected saliva samples, plus one additional sample if prompted to do so (up to 9 total samples), and ship back the sample(s) within 24 hours of sample collection

Exclusion Criteria:

Self-reported previous diagnosis of COVID-19
Currently participating in any type of clinical trial
Lives in the District of Columbia (Washington D.C.), Alaska, Hawaii, Arizona, Nevada, U.S. military base located overseas, or U.S. territories (Puerto Rico, U.S. Virgin Islands, Guam, Northern Mariana Island, or American Samoa)