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Natural History Study of COVID-19 Using Digital Wearables

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04927442
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Minority Health and Health Disparities (NIMHD) )

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....


Condition or disease
COVID-19 Virus Disease

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.

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Study Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Natural History Study of COVID-19 Using Digital Wearables
Estimated Study Start Date : January 19, 2022
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. COVID 19 Symptoms Monitoring [ Time Frame: 12 weeks ]
    Chronic covid-19 defined as =1 symptom persisting 12 weeks beyond first symptom onset.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Covid-19 patients who received a positive diagnosis (PCR or rapid test) 5 days before enrollment.
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. 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. Self-collection

kits and home tests for COVID-19 are not permitted because of the potential for inappropriate sampling and sample contamination.

  • 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.

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): NCT04927442


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

Locations
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United States, Maryland
National Institute on Minority Health and Health Disparities (NIMHD) Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Sherine M El-Toukhy, Ph.D. National Institute on Minority Health and Health Disparities (NIMHD)
Additional Information:
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Responsible Party: National Institute on Minority Health and Health Disparities (NIMHD)
ClinicalTrials.gov Identifier: NCT04927442    
Other Study ID Numbers: 10000315
000315-MD
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: September 24, 2021

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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 National Institutes of Health Clinical Center (CC) ( National Institute on Minority Health and Health Disparities (NIMHD) ):
Pneumonia
COVID-19 Sequelae
Physiological data
Clinical course
Mobile technology
Natural History
Additional relevant MeSH terms:
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COVID-19
Virus Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases