COVID-19CoronaWatchNCT04376853
CoronaWatch - Early Detection of Cardiovascular Risks in COVID-19 Via SmartWatch
An observational study of COVID-19, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
In December 2019, a new viral disease called COVID-19 emerged. It is caused by the new corona virus SARS-CoV-2. It was initially described in the chinese city of Wuhan. In the following months, the disease developed into a pandemic, which is currently an immense international challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Apple Watch Series 5
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2020to 20 May 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The study population consists of patients with COVID-19. The patients have got a cardiovascular disease or therapy with potential cardiovascular complications.
Who may be able to join
- Diagnosis of COVID-19 (detection by PCR)
- Age ≥ 18
- The patient has understood the study design and the informed consent form and has signed and dated the informed consent form
- The patient has got a cardiovascular disease or therapy with potential cardiovascular complications
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department III of Internal Medicine, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69115
About this study
In December 2019, a new viral disease called COVID-19 emerged. It is caused by the new corona virus SARS-CoV-2. It was initially described in the chinese city of Wuhan. In the following months, the disease developed into a pandemic, which is currently an immense international challenge.
So far, there is little scientific evidence on risk stratification, especially on the prognostic value of biomarkers (laboratory-chemical, clinical and digital) with regard to clinical deterioration of patients with COVID-19. Further scientific studies are needed to establish optimal risk stratification and early detection of clinical deterioration.
In this study, the investigators aim to observe patients with COVID-19 via SmartWatches on top of their clinical routine. The investigators aim to determine, whether the addition of SmartWatches enhances risk stratification, early detection of complications and prognostics in patients with COVID-19, who have cardiovascular diseases or receive medication with arrhythmogenic risk.
Read the detailed description
In December 2019, a new viral disease called COVID-19 emerged. It is caused by the new corona virus SARS-CoV-2. It was initially described in the chinese city of Wuhan. In the following months, the disease developed into a pandemic, which is currently an immense international challenge.
So far, there is little scientific evidence on risk stratification, especially on the prognostic value of biomarkers (laboratory-chemical, clinical and digital) with regard to clinical deterioration of patients with COVID-19. Further scientific studies are needed to establish optimal risk stratification and early detection of clinical deterioration.
In this study, the investigators aim to observe patients with COVID-19 via SmartWatches on top of their clinical routine. The investigators aim to determine, whether the addition of SmartWatches enhances risk stratification, early detection of complications and prognostics in patients with COVID-19, who have cardiovascular diseases or receive medication with arrhythmogenic risk.
The study is a monocentric observational study in the sense of a cohort study. 50 COVID-19 patients are aimed to be included. Patients are identified upon presentation at the COVID-19 outpatient clinic or during their stay at the COVID-19 ward at the Centre for Internal Medicine (Krehl-Klinik) at the Heidelberg University Hospital.
Since many study-relevant data are routinely collected at presentation in the outpatient clinic or during the inpatient stay, these values are being accessed (e.g. anamnesis, physical examination, ECGs, CT and laboratory values) by our study team.
The recruited subjects (n=50) receive medical care according to the instructions of the treating physicians. The treating physicians decide whether a home or inpatient quarantine is necessary and whether a specific therapy is required.
SmartWatches are provided to all subjects on the day of recruitment. These are Apple Watches (Series 5). The patient is asked to record an ECG on the Apple Watch 5 times a day (8:00 am, 11:00 am, 2:00 pm, 5:00 pm, 8:00 pm). Furthermore, the activity of the patient is recorded via the App Health.
The data collected by the Apple Watch (activity and health-related data of the App Health as well as ECGs) are accessible to the study team at any time, provided that the pseudonymised data transfer via Email has been successfully completed. In order to be able to use the Apple Watch, participants are provided with an iPhone by us.
As soon as the COVID-19 disease is cured or the participant died, the study ends for them. However, the study will be conducted for at least 14 days for each patient, even if the patient has healed earlier.
If findings relevant to the health of the patients should arise from the study-relevant data (for example the detection of cardiac arrhythmias via the Apple Watch), the investigators report these information to the treating physician and patient as soon as possible.
- Conditions
- COVID-19
- Being tested
- Apple Watch Series 5
- Keywords
- COVID-19, Wearable, SmartWatch, Prognostics, Diagnostics, Risk stratification, Apple Watch
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Watch Series 5Device
Digital monitoring via Apple Watch
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Patients with COVID-19, who have cardiovascular diseases or receive medication with arrhythmogenic risk. Receives: Device: Apple Watch Series 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker
Identification of biomarkers (laboratory-chemical, clinical, digital) for risk stratification, early detection of complications and prognosis
Measured: 3 months
Secondary outcomes (5)
Protective factors
Identification of laboratory-chemical, clinical or digitally measured protective factors, that indicate good prognosis
Measured: 3 months
SmartWatch compliance
The amount of time is compared between participants regarding the wearing of a SmartWatch as a monitoring tool
Measured: 3 months
Arrhythmias
Detection of an irregular heartbeat (PPG) as a sign of atrial or ventricular arrhythmias and correlation to intermittently recorded ECGs by SmartWatch
Measured: 3 months
QT time changes
Detection of QT time changes (prolongation) in intermittently recorded ECGs by SmartWatch and correlation with clinical variables (change of medication, fever, etc.)
Measured: 3 months
Longitudinal risk models
Application of artificial intelligence and machine learning techniques for longitudinal risk models by using collected data (e.g. metabolomics)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start15 Apr 2020
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- The German Heart Foundation, Klaus Tschira Stiftung, Germany, Freunde und Förderer der Kardiologie Heidelberg; Germany
- Responsible party
- Principal investigator, Benjamin Meder, University Hospital Heidelberg
- Investigators
- Benjamin Meder, Prof. Dr., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376853
- Sponsor's protocol ID
- CoronaWatch
- Acronym
- CoronaWatch
- Status last verified
- May 2022
- First submitted
- 20 Apr 2020
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoronaWatch - Early Detection of Cardiovascular Risks in COVID-19 Via SmartWatch
- ClinicalTrials.gov ID
- NCT04376853
- Acronym / sponsor ID
- CoronaWatch / CoronaWatch
- Conditions
- COVID-19
- Keywords
- COVID-19, Wearable, SmartWatch, Prognostics, Diagnostics, Risk stratification, Apple Watch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- The German Heart Foundation, Klaus Tschira Stiftung, Germany, Freunde und Förderer der Kardiologie Heidelberg; Germany
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 6 May 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.
In December 2019, a new viral disease called COVID-19 emerged. It is caused by the new corona virus SARS-CoV-2. It was initially described in the chinese city of Wuhan. In the following months, the disease developed into a pandemic, which is currently an immense international challenge.
So far, there is little scientific evidence on risk stratification, especially on the prognostic value of biomarkers (laboratory-chemical, clinical and digital) with regard to clinical deterioration of patients with COVID-19. Further scientific studies are needed to establish optimal risk stratification and early detection of clinical deterioration.
In this study, the investigators aim to observe patients with COVID-19 via SmartWatches on top of their clinical routine. The investigators aim to determine, whether the addition of SmartWatches enhances risk stratification, early detection of complications and prognostics in patients with COVID-19, who have cardiovascular diseases or receive medication with arrhythmogenic risk.
Detailed description
In December 2019, a new viral disease called COVID-19 emerged. It is caused by the new corona virus SARS-CoV-2. It was initially described in the chinese city of Wuhan. In the following months, the disease developed into a pandemic, which is currently an immense international challenge.
So far, there is little scientific evidence on risk stratification, especially on the prognostic value of biomarkers (laboratory-chemical, clinical and digital) with regard to clinical deterioration of patients with COVID-19. Further scientific studies are needed to establish optimal risk stratification and early detection of clinical deterioration.
In this study, the investigators aim to observe patients with COVID-19 via SmartWatches on top of their clinical routine. The investigators aim to determine, whether the addition of SmartWatches enhances risk stratification, early detection of complications and prognostics in patients with COVID-19, who have cardiovascular diseases or receive medication with arrhythmogenic risk.
The study is a monocentric observational study in the sense of a cohort study. 50 COVID-19 patients are aimed to be included. Patients are identified upon presentation at the COVID-19 outpatient clinic or during their stay at the COVID-19 ward at the Centre for Internal Medicine (Krehl-Klinik) at the Heidelberg University Hospital.
Since many study-relevant data are routinely collected at presentation in the outpatient clinic or during the inpatient stay, these values are being accessed (e.g. anamnesis, physical examination, ECGs, CT and laboratory values) by our study team.
The recruited subjects (n=50) receive medical care according to the instructions of the treating physicians. The treating physicians decide whether a home or inpatient quarantine is necessary and whether a specific therapy is required.
SmartWatches are provided to all subjects on the day of recruitment. These are Apple Watches (Series 5). The patient is asked to record an ECG on the Apple Watch 5 times a day (8:00 am, 11:00 am, 2:00 pm, 5:00 pm, 8:00 pm). Furthermore, the activity of the patient is recorded via the App Health.
The data collected by the Apple Watch (activity and health-related data of the App Health as well as ECGs) are accessible to the study team at any time, provided that the pseudonymised data transfer via Email has been successfully completed. In order to be able to use the Apple Watch, participants are provided with an iPhone by us.
As soon as the COVID-19 disease is cured or the participant died, the study ends for them. However, the study will be conducted for at least 14 days for each patient, even if the patient has healed earlier.
If findings relevant to the health of the patients should arise from the study-relevant data (for example the detection of cardiac arrhythmias via the Apple Watch), the investigators report these information to the treating physician and patient as soon as possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Device: Apple Watch Series 5Patients with COVID-19, who have cardiovascular diseases or receive medication with arrhythmogenic risk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with COVID-19. The patients have got a cardiovascular disease or therapy with potential cardiovascular complications.
Key inclusion criteria (4 listed)
- Diagnosis of COVID-19 (detection by PCR)
- Age ≥ 18
- The patient has understood the study design and the informed consent form and has signed and dated the informed consent form
- The patient has got a cardiovascular disease or therapy with potential cardiovascular complications
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apple Watch Series 5Digital monitoring via Apple Watch | Device | COVID-19 |
Primary outcome
Biomarker
Time frame: 3 months
Identification of biomarkers (laboratory-chemical, clinical, digital) for risk stratification, early detection of complications and prognosis
5 secondary outcomes
Protective factors
Time frame: 3 months
SmartWatch compliance
Time frame: 3 months
Arrhythmias
Time frame: 3 months
QT time changes
Time frame: 3 months
Longitudinal risk models
Time frame: 3 months
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 26 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Benjamin Meder, Prof. Dr. principal investigator
University Hospital Heidelberg
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, run by University Hospital Heidelberg at 1 site in Germany.
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 4 inclusion and 0 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 26 May 2022. 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 Germany. 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?
Biomarker (time frame: 3 months). 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 26 May 2022.