Natural History Study of COVID-19 Using Digital Wearables

Study Description:

COVID-19 patients experience varying degrees of illness. Factors associated with prolonged illness remain unknown especially in non-hospitalized patients. 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:

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 at 3 weeks beyond first symptom onset or test positivity, whichever comes first.

Secondary endpoint:

Chronic COVID-19 defined as >=1 symptom at 12 weeks beyond first symptom onset or test positivity, whichever comes first.

• 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:

• 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)
• 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
• 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)
• 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.
• Requirement of hospitalization at enrollment.
• 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.