CClinicalTrials.gg
CompletedNCT04623138Updated Jan 11, 2022

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

An observational study in Covid19 and SARS-CoV Infection, sponsored by Evidation Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Evidation Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
847
Ages
18 Years and older
Sex
All
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Study summary

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

02

Conditions studied

  • Covid19
  • SARS-CoV Infection

Keywords

  • COVID-19
  • SARS-Cov Infection
  • SARS-CoV-2
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 847 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Evidation Health is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
847 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

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

    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.

    Time frame: Through study completion, an average of 7 months

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

    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.

    Time frame: Through study completion, an average of 7 months

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+).

    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.)

    Time frame: Through study completion, an average of 7 months

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Study locations

1 site
  • Evidation Health
    San Mateo, California 94402, United States
08

References and documents

Publications

  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. PubMed 32091533 ↗
  • Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10. PubMed 32150748 ↗
  • Arons MM, Hatfield KM, Reddy SC, Kimball A, James A, Jacobs JR, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Dyal JW, Harney J, Chisty Z, Bell JM, Methner M, Paul P, Carlson CM, McLaughlin HP, Thornburg N, Tong S, Tamin A, Tao Y, Uehara A, Harcourt J, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Montgomery P, Stone ND, Clark TA, Honein MA, Duchin JS, Jernigan JA; Public Health-Seattle and King County and CDC COVID-19 Investigation Team. Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility. N Engl J Med. 2020 May 28;382(22):2081-2090. doi: 10.1056/NEJMoa2008457. Epub 2020 Apr 24. PubMed 32329971 ↗
  • Gandhi M, Yokoe DS, Havlir DV. Asymptomatic Transmission, the Achilles' Heel of Current Strategies to Control Covid-19. N Engl J Med. 2020 May 28;382(22):2158-2160. doi: 10.1056/NEJMe2009758. Epub 2020 Apr 24. No abstract available. PubMed 32329972 ↗
  • CDC COVID-19 Response Team. Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019 - United States, February 12-March 28, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):382-386. doi: 10.15585/mmwr.mm6913e2. PubMed 32240123 ↗
  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. PubMed 32109013 ↗
  • Chow EJ, Schwartz NG, Tobolowsky FA, Zacks RLT, Huntington-Frazier M, Reddy SC, Rao AK. Symptom Screening at Illness Onset of Health Care Personnel With SARS-CoV-2 Infection in King County, Washington. JAMA. 2020 May 26;323(20):2087-2089. doi: 10.1001/jama.2020.6637. PubMed 32301962 ↗
  • Han C, Duan C, Zhang S, Spiegel B, Shi H, Wang W, Zhang L, Lin R, Liu J, Ding Z, Hou X. Digestive Symptoms in COVID-19 Patients With Mild Disease Severity: Clinical Presentation, Stool Viral RNA Testing, and Outcomes. Am J Gastroenterol. 2020 Jun;115(6):916-923. doi: 10.14309/ajg.0000000000000664. PubMed 32301761 ↗
  • Menni C, Valdes AM, Freidin MB, Sudre CH, Nguyen LH, Drew DA, Ganesh S, Varsavsky T, Cardoso MJ, El-Sayed Moustafa JS, Visconti A, Hysi P, Bowyer RCE, Mangino M, Falchi M, Wolf J, Ourselin S, Chan AT, Steves CJ, Spector TD. Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med. 2020 Jul;26(7):1037-1040. doi: 10.1038/s41591-020-0916-2. Epub 2020 May 11. PubMed 32393804 ↗
  • Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10. PubMed 32291094 ↗
  • Poyiadji N, Shahin G, Noujaim D, Stone M, Patel S, Griffith B. COVID-19-associated Acute Hemorrhagic Necrotizing Encephalopathy: Imaging Features. Radiology. 2020 Aug;296(2):E119-E120. doi: 10.1148/radiol.2020201187. Epub 2020 Mar 31. No abstract available. PubMed 32228363 ↗
  • Landa N, Mendieta-Eckert M, Fonda-Pascual P, Aguirre T. Chilblain-like lesions on feet and hands during the COVID-19 Pandemic. Int J Dermatol. 2020 Jun;59(6):739-743. doi: 10.1111/ijd.14937. Epub 2020 Apr 24. No abstract available. PubMed 32329897 ↗
  • Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum In: JAMA. 2020 May 26;323(20):2098. doi: 10.1001/jama.2020.7681. PubMed 32320003 ↗
  • 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
  • Grant MC, Geoghegan L, Arbyn M, Mohammed Z, McGuinness L, Clarke EL, Wade RG. The prevalence of symptoms in 24,410 adults infected by the novel coronavirus (SARS-CoV-2; COVID-19): A systematic review and meta-analysis of 148 studies from 9 countries. PLoS One. 2020 Jun 23;15(6):e0234765. doi: 10.1371/journal.pone.0234765. eCollection 2020. PubMed 32574165 ↗
  • Shapiro A, Marinsek N, Clay I, Bradshaw B, Ramirez E, Min J, Trister A, Wang Y, Althoff T, Foschini L. Characterizing COVID-19 and Influenza Illnesses in the Real World via Person-Generated Health Data. Patterns (N Y). 2020 Dec 13;2(1):100188. doi: 10.1016/j.patter.2020.100188. eCollection 2021 Jan 8. PubMed 33506230 ↗
  • 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

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04623138
Lead sponsor
Evidation Health
Collaborators
Biomedical Advanced Research and Development Authority, Eli Lilly and Company, Bill and Melinda Gates Foundation, Vir Biotechnology, Inc., United States Department of Defense
Responsible party
Sponsor
First posted
Nov 10, 2020
Start date
Nov 4, 2020
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021
Last update
Jan 11, 2022

Study contacts

Ernesto Ramirez, PhD
principal investigator · Evidation Health
Luca Foschini, PhD
principal investigator · Evidation Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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