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Natural History Study of COVID-19 Using Digital Wearables

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ClinicalTrials.gov Identifier: NCT04927442
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : July 30, 2021
Sponsor:
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 July 30, 2021
Estimated Study Start Date August 4, 2021
Estimated Primary Completion Date January 31, 2022   (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
Change History
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 Covid-19 patients experience varying degrees of illness, ranging from no/mild symptoms to critical illness/death. A subset of covid-19 patients experiences long-term sequelae of covid-19 regardless of the severity of the disease initially. Predicting where a patient falls on the illness spectrum is important to allocate sparse resources and intervene medically at an optimal time. With current recommendations dictating that covid-19 patients self-isolate and care for themselves at home, the clinical course of covid-19 in most patients remains largely unknown. Preliminary prognostic and diagnostic models of covid-19 severity rely on clinical data primarily from inpatients with advanced disease where clinical indicators such as blood oxygen saturation and respiratory rate have been predictive of covid-19 trajectories. Digital wearables allow for a continuous collection of such physiological data that can shed light on the onset and progression of covid-19 symptoms in patient groups, particularly given its varying severity and differential rate of progression that are associated with key demographics and risk profiles, primarily underlying chronic conditions. We hypothesize that biometrics collected via a digital wristband are associated with patient-reported post-acute covid-19 sequalae. This is a prospective, natural history study of covid-19 among a cohort of 550 patients with positive covid-19 diagnosis who volunteer to participate in the study.
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 <=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 <=5 days before enrollment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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, 2022   (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 rapid test) <=5 days before enrollment. 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.
  • Owns supported device (i.e., smartphone or a tablet) compliant with the specifications listed below:

    • Android with an operating system of 6.0 or newer that implement Bluetooth Low Energy (BLE) standard, which is general available in Bluetooth 4 or newer
    • iPhone 5s, SE, 6/6 plus, 6s/6s plus, 7/7 plus, 8/8 plus, X, XS, XR, 11, 11 Pro
    • iPad mini 2, 3, 4; iPad 5th, 6th, 7th, 8th generation; iPad Air 1/2; iPad Air 3rd generation; 9.7- inch iPad Pro; 10.5-inch iPad Pro; 11-inch iPad pro 1st and 2nd generation; 12.9-inch iPad pro 1st, 2nd, 3rd, 4th generation
  • 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 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 data required for the study such as medical history data and contact information for a close family member).
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
Removed Location Countries  
 
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
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute on Minority Health and Health Disparities (NIMHD) )
Study Sponsor National Institute on Minority Health and Health Disparities (NIMHD)
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 June 25, 2021