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Completed

NCT Number: NCT04623138

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV Infection Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evidation Health

San Mateo, California, 94402, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection

    Time frame: 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.

  2. Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data

    Time frame: 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 outcomes

  1. 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+).

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Evidation Health

Industry

Collaborators

  • Bill and Melinda Gates Foundation
  • Biomedical Advanced Research and Development Authority
  • Eli Lilly and Company
  • United States Department of Defense
  • Vir Biotechnology, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2020
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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