Covid19WEAICORNCT04605965
WEAICOR: Wearables to Investigate the Long Term Cardiovascular and Behavioral Impacts of COVID-19
An observational study of Covid19 and Cardiovascular Complication, run by Tulane University at 2 sites in United States.
Trial summary
This is an observational COVID-19 study that uses wearable health monitoring technology to follow COVID-19 positive individuals to monitor persistent symptoms and any potential long-term complications or cardiovascular and behavioral impacts from the disease. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Cardiovascular Complication, Behavioral Changes
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jun 2020to 8 Jun 2025
- How long will I take part?
- 24 Months
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a positive COVID-19 diagnosis.
Who may be able to join
- Positive COVID-19 diagnosis
- Ages 18 to 120
- Access to WiFi
Who cannot join
- Negative COVID-19 diagnosis
- Age younger than 18 and older than 120
- Lack of access to WiFi
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tulane University, TRIAD Center
New Orleans, Louisiana, 70119
Tulane University
New Orleans, Louisiana, 70119
About this study
Official title: Wearable Health Data to Investigate Long-term Cardiovascular and Behavioral Health Outcomes in COVID-19 Patients After Discharge: The WEAICOR Study
This is an observational COVID-19 study that uses wearable health monitoring technology to follow COVID-19 positive individuals to monitor persistent symptoms and any potential long-term complications or cardiovascular and behavioral impacts from the disease.
Read the detailed description
Participants will wear a Biostrap wristband device that captures high-fidelity, raw photoplethysmography (PPG) waveforms and collects important indicators of heart and mental health, including heart rate, heart rate variability, pulse points, oxygen saturation and sleep patterns. Biometric data will be collected and participants will be alerted if any measurements are outside their normal range.
Researchers are recruiting 200 participants who were diagnosed with COVID-19.
- Conditions
- Covid19, Cardiovascular Complication, Behavioral Changes
- Keywords
- Digital Health
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major cardiovascular events
Including arrhythmia occurrence or recurrence, congestive heart failure, myocardial infarction, cardiomyopathy and ischemic stroke.
Measured: 12 Months
Incidence of atrial arrhythmia
Including atrial fibrillation, atrial flutter, atrial tachycardia
Measured: 12 Months
Mental health effect of COVID-19 measured by incidence of Generalized Anxiety Disorder (GAD) using Generalized Anxiety Disorder 7-item (GAD-7) Scale
Generalized Anxiety Disorder 7-item (GAD-7) Scale includes 7 questions to be answered by the patient, each answer is scored from 0 to 3, and the scale range is from 0 to 21, with a higher number representing more severe GAD level
Measured: 12 Months
Mental health effect of COVID-19 measured by incidence of depression using Beck Depression Fast Screen Scale
Beck Depression Fast Screen Scale includes 21 questions to be answered by the patient scored from 0 to 3, and the scale range is from 0 to above 40, with a higher number representing more severe depression level
Measured: 12 Months
Mental health effect of COVID-19 measured by incidence of Post Traumatic Stress Syndrome (PTSD) using the Post Traumatic Stress Disorder Checklist- Standard Form (PCL-S) scale
Post Traumatic Stress Disorder Checklist- Standard Form (PCL-S) Scale includes 20 questions to be answered by the patient scored from 1 to 5. Total symptom severity score (ranging 0-80) can be obtained by summing the scores for each of the 20 items. Higher number represents more likely that the patient has PTSD.
Measured: 12 Months
Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of alcohol survey
Baseline use of alcohol survey includes ten questions to be answered by the patient scored from 0 to 4 with a higher number representing increased alcohol consumption
Measured: 12 Months
Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of drugs survey
Baseline use of drugs survey includes ten questions to be answered by the patient scored from 0 to 4 with a higher number representing increased drug use
Measured: 12 Months
Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of nicotine products survey
Baseline use of nicotine products survey includes 4 questions to be answered by the patient to find out which nicotine products the patient is using if any and how many cigarettes they're smoking per day
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start9 Jun 2020
- Primary completion8 Jun 2025
- Study completion8 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Biostrap
- Responsible party
- Sponsor
- Investigators
- Nassir Marrouche, MD, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605965
- Sponsor's protocol ID
- 2020-678
- Acronym
- WEAICOR
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2020
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data may be used for secondary analyses/research on COVID19 complications
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Health Data to Investigate Long-term Cardiovascular and Behavioral Health Outcomes in COVID-19 Patients After Discharge: The WEAICOR Study
- ClinicalTrials.gov ID
- NCT04605965
- Acronym / sponsor ID
- WEAICOR / 2020-678
- Conditions
- Covid19, Cardiovascular Complication, Behavioral Changes
- Keywords
- Digital Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Biostrap
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 8 Jun 2025 (actual)
- Study completion
- 8 Jun 2025 (actual)
- First posted
- 28 Oct 2020 (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.
This is an observational COVID-19 study that uses wearable health monitoring technology to follow COVID-19 positive individuals to monitor persistent symptoms and any potential long-term complications or cardiovascular and behavioral impacts from the disease.
Detailed description
Participants will wear a Biostrap wristband device that captures high-fidelity, raw photoplethysmography (PPG) waveforms and collects important indicators of heart and mental health, including heart rate, heart rate variability, pulse points, oxygen saturation and sleep patterns. Biometric data will be collected and participants will be alerted if any measurements are outside their normal range.
Researchers are recruiting 200 participants who were diagnosed with COVID-19.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a positive COVID-19 diagnosis.
Key inclusion criteria (3 listed)
- Positive COVID-19 diagnosis
- Ages 18 to 120
- Access to WiFi
Key exclusion criteria (3 listed)
- Negative COVID-19 diagnosis
- Age younger than 18 and older than 120
- Lack of access to WiFi
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
Incidence of major cardiovascular events
Time frame: 12 Months
Including arrhythmia occurrence or recurrence, congestive heart failure, myocardial infarction, cardiomyopathy and ischemic stroke.
Incidence of atrial arrhythmia
Time frame: 12 Months
Including atrial fibrillation, atrial flutter, atrial tachycardia
Mental health effect of COVID-19 measured by incidence of Generalized Anxiety Disorder (GAD) using Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time frame: 12 Months
Generalized Anxiety Disorder 7-item (GAD-7) Scale includes 7 questions to be answered by the patient, each answer is scored from 0 to 3, and the scale range is from 0 to 21, with a higher number representing more severe GAD level
Mental health effect of COVID-19 measured by incidence of depression using Beck Depression Fast Screen Scale
Time frame: 12 Months
Beck Depression Fast Screen Scale includes 21 questions to be answered by the patient scored from 0 to 3, and the scale range is from 0 to above 40, with a higher number representing more severe depression level
Mental health effect of COVID-19 measured by incidence of Post Traumatic Stress Syndrome (PTSD) using the Post Traumatic Stress Disorder Checklist- Standard Form (PCL-S) scale
Time frame: 12 Months
Post Traumatic Stress Disorder Checklist- Standard Form (PCL-S) Scale includes 20 questions to be answered by the patient scored from 1 to 5. Total symptom severity score (ranging 0-80) can be obtained by summing the scores for each of the 20 items. Higher number represents more likely that the patient has PTSD.
Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of alcohol survey
Time frame: 12 Months
Baseline use of alcohol survey includes ten questions to be answered by the patient scored from 0 to 4 with a higher number representing increased alcohol consumption
Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of drugs survey
Time frame: 12 Months
Baseline use of drugs survey includes ten questions to be answered by the patient scored from 0 to 4 with a higher number representing increased drug use
Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of nicotine products survey
Time frame: 12 Months
Baseline use of nicotine products survey includes 4 questions to be answered by the patient to find out which nicotine products the patient is using if any and how many cigarettes they're smoking per day
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 5 Mar 2026.
- Individual participant dataSharing planned: Undecided. De-identified data may be used for secondary analyses/research on COVID19 complications
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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.
Nassir Marrouche, MD principal investigator
Tulane University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Cardiovascular Complication, run by Tulane University at 2 sites 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 3 inclusion and 3 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incidence of major cardiovascular events (time frame: 12 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.