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

NCT04623138 | Completed

• 1 other identifier: COVID Signals
• Study Type: observational
• Target: 847
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19; SARS-CoV Infection

Keywords

COVID-19; SARS-Cov Infection; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• 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.

  Through study completion, an average of 7 months

• 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.

  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+).

  Through study completion, an average of 7 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Evidation Health

San Mateo, California, 94402, United States

Location

Related Publications (17)

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 32150748 BACKGROUND

• 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.

  PMID: 32329971 BACKGROUND

• 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.

  PMID: 32329972 BACKGROUND

• 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.

  PMID: 32240123 BACKGROUND

• 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.

  PMID: 32109013 BACKGROUND

• 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.

  PMID: 32301962 BACKGROUND

• 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.

  PMID: 32301761 BACKGROUND

• 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.

  PMID: 32393804 BACKGROUND

• 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.

  PMID: 32291094 BACKGROUND

• 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.

  PMID: 32228363 BACKGROUND

• 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.

  PMID: 32329897 BACKGROUND

• 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.

  PMID: 32320003 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32574165 BACKGROUND

• 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.

  PMID: 33506230 BACKGROUND

• 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

  BACKGROUND

Related Links

• Statement on the second meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV). (n.d.)
• COVID-19 Map. (n.d.)
• Modes of transmission of virus causing COVID-19: Implications for IPC precaution recommendations. (n.d.).
• Coronavirus disease 2019 (COVID-19) Situation Report - 73 (Issue brief No. 73).
• World Health Organization. (2020, April 1). COVID-19 - Virtual Press Conference \[Press release\].
• UCSF TemPredict Study. (n.d.).
• COVID-19 Wearables Study. (n.d.).
• Coronavirus. (n.d.)
• Phosphorus COVID-19 RT-QPCR Test - Letter of Authorization
• Oragene-Dx OGD-510
• Coronavirus Disease 2019 (COVID-19) 2020 Interim Case Definition, Approved April 5, 2020

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

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ernesto Ramirez, PhD

  Evidation Health

  PRINCIPAL INVESTIGATOR

• Luca Foschini, PhD

  Evidation Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 10, 2020
• Study Start: November 4, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)