Natural History Study of COVID-19 Using Digital Wearables

• ClinicalTrials.gov Identifier: NCT04927442
• Recruitment Status: Recruiting
• First Posted: June 16, 2021
• Last Update Posted: September 6, 2022
• Sponsor: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute on Minority Health and Health Disparities (NIMHD) )

Tracking Information

• First Submitted Date: June 15, 2021
• First Posted Date: June 16, 2021
• Last Update Posted Date: September 6, 2022
• Actual Study Start Date: October 11, 2021
• Estimated Primary Completion Date: January 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 15, 2021)

COVID 19 Symptoms Monitoring [ Time Frame: 3 weeks ]

Long covid-19 defined as =1 symptom persisting 3 weeks beyond first symptom onset or test positivity, whichever comes first, for outpatients and post hospital discharge for inpatients.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 15, 2021)

COVID 19 Symptoms Monitoring [ Time Frame: 12 weeks ]

Chronic covid-19 defined as =1 symptom persisting 12 weeks beyond first symptom onset.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Natural History Study of COVID-19 Using Digital Wearables
• Official Title: A Prospective Natural History Study of COVID-19 Using Digital Wearables

Brief Summary

Background:

People with COVID-19 have varying degrees of illness. It can range from no or mild symptoms to critical illness and death. Some people with COVID-19 have long-term effects regardless of the severity of their disease initially. Researchers want to learn more to see if they can better predict where a person may fall on the illness spectrum.

Objective:

To follow and record symptoms of COVID-19 to see how it progresses in people and why some people stay sick longer than others.

Eligibility:

People ages 18-65 who received a COVID-19 positive test result in the 72 hours before their enrollment in the study.

Design:

Participants will complete a 30-minute baseline survey. They will answer questions about themselves and their health.

Participants will get a digital wristband and temperature sensor in the mail. They will get instructions on how to set up and wear the devices. They will download a mobile application on their phone. The app will collect data from the devices.

Participants will wear the wristband and sensor every day for the first month. Then they will wear the devices for a total of 40 days over the next 5 months. On the days they wear the devices, they will answer a 2-question health survey via the app.

Participants will answer a 20-minute online survey about their health every 30 days.

If participants are hospitalized, a family member or close friend will be asked to complete a brief 7-minute online survey about their hospital stay and treatment.

Participants will be sent alerts and reminders throughout the study. Participation will last for 6 months.

Detailed Description

Study Description:

COVID-19 patients experience varying degrees of illness. Factors associated with prolonged illness remain unknown especially in outpatients. This study uses digital wearables to collect high-resolution physiological data to understand the clinical course of COVID-19 in patients with a positive COVID-19 diagnosis. We hypothesize that wearables-based physiological data are associated with COVID-19 post-acute sequelae.

Objectives:<TAB>

To identify digital wearables-based physiological data that are associated with COVID-19 post-acute sequelae.

Endpoints:

Primary endpoint:

Long COVID-19 defined as >=1 symptom persisting 3 weeks beyond first symptom onset for outpatients and post hospital discharge for inpatients.

Secondary endpoint:

Chronic COVID-19 defined as >=1 symptom persisting 12 weeks beyond first symptom onset.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Covid-19 patients who received a positive diagnosis (PCR or rapid test) 5 days before enrollment.
• Condition: COVID-19 Virus Disease
• Intervention: Not Provided

Study Groups/Cohorts

Covid-19 patients

Patients, male or female, 18 to 65 years old, who tested positive for COVID-19 (PCR or rapid test) =5 days before enrollment.

Publications *

• Mahase E. Covid-19: What do we know about "long covid"? BMJ. 2020 Jul 14;370:m2815. doi: 10.1136/bmj.m2815. No abstract available.
• Wynants L, Van Calster B, Collins GS, Riley RD, Heinze G, Schuit E, Bonten MMJ, Dahly DL, Damen JAA, Debray TPA, de Jong VMT, De Vos M, Dhiman P, Haller MC, Harhay MO, Henckaerts L, Heus P, Kammer M, Kreuzberger N, Lohmann A, Luijken K, Ma J, Martin GP, McLernon DJ, Andaur Navarro CL, Reitsma JB, Sergeant JC, Shi C, Skoetz N, Smits LJM, Snell KIE, Sperrin M, Spijker R, Steyerberg EW, Takada T, Tzoulaki I, van Kuijk SMJ, van Bussel B, van der Horst ICC, van Royen FS, Verbakel JY, Wallisch C, Wilkinson J, Wolff R, Hooft L, Moons KGM, van Smeden M. Prediction models for diagnosis and prognosis of covid-19: systematic review and critical appraisal. BMJ. 2020 Apr 7;369:m1328. doi: 10.1136/bmj.m1328. Erratum In: BMJ. 2020 Jun 3;369:m2204.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 15, 2021): 550
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2025
• Estimated Primary Completion Date: January 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

• INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all the following criteria:

• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 to 65. The pediatric population <18 years differs from adults >18 years in infection rates, symptom manifestation, and outcomes (e.g., multi- inflammatory syndrome). Although population 12 and older is now eligible to receive the vaccine, population over 65 was the first eligible age group to receive the vaccine in the US. Furthermore, protections are in place to reduce transmission among the elderly in general and in nursing homes in particular.
• Documentation of a SARS-Cov-19 positive test (PCR or antigen/rapid test) <=5 days before enrollment issued by a public or private healthcare facility, provider or practitioner, or a COVID-19 testing lab or center or pharmacy. Recruitment materials list patients must be within 3 days of a positive test, which gives the research team 2 days to enroll patients in the study. Tests with no documented positive result (e.g., self-collection kits for home tests for COVID-19) are not permitted because it is difficult to ascertain the test date, time, and test result.

• Owns or has access to supported device (i.e., smartphone or a tablet) that compliant with the specifications listed below and with an existing cellular data plan:

  1. Android phones and tables with an operating system of 6.0 or newer (6.0, Bluetooth 4.2 or Bluetooth 5.0 support, and which implement Bluetooth Low Energy (BLE) standard)
  2. iPhone SE (1st, 2nd generation), 6s/6s plus, 7/7 plus, 8/8 plus, X, XS, XR, 11, 11 Pro, 11 Pro Max, 12, 12 Mini, 12 Pro, 12 Pro Max
  3. iPad mini 4; iPad mini (5th generation), iPad (5th, 6th, 7th, 8th generation); iPad Air 2; iPad Air (3rd, 4th generation); 9.7- inch iPad Pro; 10.5-inch iPad Pro; 11-inch iPad pro (1st, 2nd, and 3rd generation); 12.9-inch iPad pro (1st, 2nd, 3rd, 4th, 5th generation)
  4. Devices released in 2021 and afterward that are compatible with the Biostrap app.
• Speaks English. Non-English speakers will be unable to use the Biostrap mobile app. Although efforts are currently underway to provide the app in Spanish, the current app is only available in English.
• Agreement to adhere to lifestyle considerations throughout the study duration (i.e., wear a digital wristband and temperature patch).
• Ability of subject to understand and willingness to consent to the participate.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

• Enrollment in clinical trials on experimental COVID-19 therapeutics at baseline. Patients will be instructed to alert the NIMHD research team if a patient participates in a clinical trial after enrollment in this study.
• Upon recruitment, requires invasive or non-invasive assisted ventilation.
• Inability to consent.
• Unwillingness to comply with study procedures (i.e., wearing a wristband and temperature patch, downloading a mobile application, providing proof of positive COVID-19 test, providing data required for the study such as medical history data and contact information for two close kin).
• Participants residing outside US mainland.
• Known history of allergic reaction to adhesives.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sherine M El-Toukhy, Ph.D.; (301) 594-4743; sherine.el-toukhy@nih.gov

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04927442
• Other Study ID Numbers: 10000315; 000315-MD
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Minority Health and Health Disparities (NIMHD) )
• Original Responsible Party: Same as current
• Current Study Sponsor: National Institute on Minority Health and Health Disparities (NIMHD)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sherine M El-Toukhy, Ph.D.; National Institute on Minority Health and Health Disparities (NIMHD)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: August 25, 2022