Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04376853 |
| Other study ID # |
CoronaWatch |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2020 |
| Est. completion date |
May 20, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University Hospital Heidelberg |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
