Clinical trial NCT04623138: A Virtual Prospective Study Exploring Activity Trackers and COVID-19 Infections
Official title: A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV Infection
Keywords: COVID-19
SARS-Cov Infection
SARS-CoV-2
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
name: Eli Lilly and Company
name: Bill and Melinda Gates Foundation
name: Vir Biotechnology, Inc.
name: United States Department of Defense
First posted: 2020-11-10
Enrollment: 847
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants (ages 18+) who reside in the contiguous United States and are at elevated risk of contracting COVID-19.

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


Eligibility criteria: 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)

Primary outcomes:
measure: Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection
timeFrame: Through study completion, an average of 7 months
measure: Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data
timeFrame: Through study completion, an average of 7 months
Secondary outcomes:
measure: 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+).
timeFrame: Through study completion, an average of 7 months
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
affiliation: Evidation Health
name: Ernesto Ramirez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evidation Health
name: Luca Foschini, PhD
role: PRINCIPAL_INVESTIGATOR
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