COVID-19 Virus DiseaseNCT04927442
Natural History Study of COVID-19 Using Digital Wearables
An observational study of COVID-19 Virus Disease, run by National Institute on Minority Health and Health Disparities (NIMHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Virus Disease
- How many people
- 464 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Covid-19 patients who received a positive diagnosis (PCR or rapid test) 5 days before enrollment.
Who may be able to join
- 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)
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Minority Health and Health Disparities (NIMHD)
Bethesda, Maryland, 20892
About this study
Official title: A Prospective Natural History Study of COVID-19 Using Digital Wearables
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.
Read more
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.
Read the detailed description
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.
- Conditions
- COVID-19 Virus Disease
- Keywords
- Pneumonia, COVID-19 Sequelae, Physiological data, Clinical course, Mobile technology, Natural History
- Medical subject headings
- COVID-19, Pneumonia, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID 19 Symptoms Monitoring
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.
Measured: 3 weeks
Secondary outcomes (1)
COVID 19 Symptoms Monitoring
Chronic covid-19 defined as =1 symptom persisting 12 weeks beyond first symptom onset.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start11 Oct 2021
- Primary completion5 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Minority Health and Health Disparities (NIMHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sherine M El-Toukhy, Ph.D., Principal investigator, National Institute on Minority Health and Health Disparities (NIMHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927442
- Sponsor's protocol ID
- 10000315
- Other IDs
- 000315-MD
- Status last verified
- 25 Apr 2025
- First submitted
- 15 Jun 2021
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32665317Wynants 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.
PubMed 32265220El-Toukhy S, Hegeman P, Zuckerman G, Das AR, Moses N, Troendle J, Powell-Wiley TM. Study of Postacute Sequelae of COVID-19 Using Digital Wearables: Protocol for a Prospective Longitudinal Observational Study. JMIR Res Protoc. 2024 Aug 16;13:e57382. doi: 10.2196/57382.
PubMed 39150750El-Toukhy S, Hegeman P, Zuckerman G, Anirban RD, Moses N, Troendle JF, Powell-Wiley TM. A prospective natural history study of post acute sequalae of COVID-19 using digital wearables: Study protocol. Res Sq [Preprint]. 2023 Dec 7:rs.3.rs-3694818. doi: 10.21203/rs.3.rs-3694818/v1.
PubMed 38105936
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Natural History Study of COVID-19 Using Digital Wearables
- ClinicalTrials.gov ID
- NCT04927442
- Acronym / sponsor ID
- 10000315
- Conditions
- COVID-19 Virus Disease
- Keywords
- Pneumonia, COVID-19 Sequelae, Physiological data, Clinical course, Mobile technology, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- National Institute on Minority Health and Health Disparities (NIMHD)US National Institutes of Health
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Covid-19 patients who received a positive diagnosis (PCR or rapid test) 5 days before enrollment.
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
COVID 19 Symptoms Monitoring
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 32665317Mahase E. Covid-19: What do we know about "long covid"? BMJ. 2020 Jul 14;370:m2815. doi: 10.1136/bmj.m2815. No abstract available.
- Background: PubMed 32265220Wynants 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.
- Derived from this study: PubMed 39150750El-Toukhy S, Hegeman P, Zuckerman G, Das AR, Moses N, Troendle J, Powell-Wiley TM. Study of Postacute Sequelae of COVID-19 Using Digital Wearables: Protocol for a Prospective Longitudinal Observational Study. JMIR Res Protoc. 2024 Aug 16;13:e57382. doi: 10.2196/57382.
- Derived from this study: PubMed 38105936El-Toukhy S, Hegeman P, Zuckerman G, Anirban RD, Moses N, Troendle JF, Powell-Wiley TM. A prospective natural history study of post acute sequalae of COVID-19 using digital wearables: Study protocol. Res Sq [Preprint]. 2023 Dec 7:rs.3.rs-3694818. doi: 10.21203/rs.3.rs-3694818/v1.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherine M El-Toukhy, Ph.D. principal investigator
National Institute on Minority Health and Health Disparities (NIMHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Virus Disease, run by National Institute on Minority Health and Health Disparities (NIMHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID 19 Symptoms Monitoring (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04927442, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.