NCT04376853

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

April 20, 2020

Last Update Submit

May 20, 2022

Conditions

Keywords

COVID-19WearableSmartWatchPrognosticsDiagnosticsRisk stratificationApple Watch

Outcome Measures

Primary Outcomes (1)

  • Biomarker

    Identification of biomarkers (laboratory-chemical, clinical, digital) for risk stratification, early detection of complications and prognosis

    3 months

Secondary Outcomes (5)

  • Protective factors

    3 months

  • SmartWatch compliance

    3 months

  • Arrhythmias

    3 months

  • QT time changes

    3 months

  • Longitudinal risk models

    3 months

Study Arms (1)

COVID-19

Patients with COVID-19, who have cardiovascular diseases or receive medication with arrhythmogenic risk.

Device: Apple Watch Series 5

Interventions

Digital monitoring via Apple Watch

COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department III of Internal Medicine, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Benjamin Meder, Prof. Dr.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 20, 2020

First Posted

May 6, 2020

Study Start

April 15, 2020

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations