CoronaWatch - Early Detection of Cardiovascular Risks in COVID-19 Via SmartWatch (CoronaWatch)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Device: Apple Watch Series 5

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69115
      • Department III of Internal Medicine, University Hospital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with COVID-19. The patients have got a cardiovascular disease or therapy with potential cardiovascular complications.

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19; Patients with COVID-19, who have cardiovascular diseases or receive medication with arrhythmogenic risk.	Device: Apple Watch Series 5; Digital monitoring via Apple Watch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker	Identification of biomarkers (laboratory-chemical, clinical, digital) for risk stratification, early detection of complications and prognosis	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protective factors	Identification of laboratory-chemical, clinical or digitally measured protective factors, that indicate good prognosis	3 months
SmartWatch compliance	The amount of time is compared between participants regarding the wearing of a SmartWatch as a monitoring tool	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	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.)	3 months
Longitudinal risk models	Application of artificial intelligence and machine learning techniques for longitudinal risk models by using collected data (e.g. metabolomics)	3 months

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Collaborators: The German Heart Foundation; Klaus Tschira Stiftung, Germany; Freunde und Förderer der Kardiologie Heidelberg; Germany
• Investigators: Principal Investigator: Benjamin Meder, Prof. Dr., University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Risk stratification; Diagnostics; Wearable; Apple Watch; SmartWatch; Prognostics
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CoronaWatch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No