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

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ClinicalTrials.gov Identifier: NCT04623138
Recruitment Status : Not yet recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborators:
Biomedical Advanced Research and Development Authority
Eli Lilly and Company
Bill and Melinda Gates Foundation
Vir Biotechnology, Inc.
United States Department of Defense
Information provided by (Responsible Party):
Evidation Health

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
Covid19 SARS-CoV Infection

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Study Type : Observational
Estimated Enrollment : 950 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
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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.

  3. Development of analytical models for real-time COVID-19 surveillance at the individual and population levels [ 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 Outcome Measures :
  1. Performance of the analytical models for real-time COVID-19 surveillance at the individual and population levels. [ Time Frame: Through study completion, an average of 7 months ]
    Model performance and accuracy characteristics of the analytical models on hold out data sets


Biospecimen Retention:   Samples Without DNA
The Phosphorus COVID-19 RT-qPCR Test will be used for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens that are either self-collected at home or in a healthcare setting using the Oragene Dx OGD-510 collection device


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623138


Contacts
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Contact: Ernesto Ramirez, PhD (415) 429-1541 study+covidsignals@myachievement.com
Contact: Joyce HN Nortey, MPH, MSBH (415) 429-1541 study+covidsignals@myachievement.com

Sponsors and Collaborators
Evidation Health
Biomedical Advanced Research and Development Authority
Eli Lilly and Company
Bill and Melinda Gates Foundation
Vir Biotechnology, Inc.
United States Department of Defense
Investigators
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Principal Investigator: Ernesto Ramirez, PhD Evidation Health
Principal Investigator: Luca Foschini, PhD Evidation Health
Additional Information:
Publications:
Poyiadji, N., Shahin, G., Noujaim, D., et al. (2020). COVID-19-associated Acute Hemorrhagic Necrotizing Encephalopathy: CT and MRI Features. Radiology, 201187. Advance online publication. https://doi.org/10.1148/radiol.2020201187
Grady, D. (2020, June 11). Covid-19 Patient Gets Double Lung Transplant, Offering Hope for Others. Retrieved from https://www.nytimes.com/2020/06/11/health/coronavirus-lung-transplant.html
Marinsek N, Shapiro A, Clay I, et al. Measuring COVID-19 and Influenza in the Real World via Person-Generated Health Data. Published 2020 May 30. doi:10.1101/2020.05.28.20115964
Auwaerter, PA. "Coronavirus COVID-19 (SARS-CoV-2)." Johns Hopkins ABX Guide, Johns Hopkins Medicine, 2020. https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540 747/all/Coronavirus_COVID_19__SARS_CoV_2_#2

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Responsible Party: Evidation Health
ClinicalTrials.gov Identifier: NCT04623138    
Other Study ID Numbers: COVID Signals
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evidation Health:
COVID-19
SARS-Cov Infection
SARS-CoV-2
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases