NCT04395664

Brief Summary

The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if continuous ECG monitoring can be used to understand the contribution of COVID-19 infection in the acute phase to the development of cardiac arrhythmias, especially focusing on cardiovascular outcomes. In all patients included, the investigators aim to examine if continuous ECG monitoring - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

May 19, 2020

Last Update Submit

September 6, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis

    4 months

  • Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis

    4 months

Secondary Outcomes (3)

  • Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis

    4 months

  • Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis

    4 months

  • Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis

    4 months

Interventions

ECG monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In.patients from hospitals of the greater Copenhagen area

You may qualify if:

  • All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 \> 18 years of age.

You may not qualify if:

  • Persons not able to cooperate
  • Persons unable to understand and sign "informed consent"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Herlev & Gentofte Hospital

Copenhagen, Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Research Director

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 20, 2020

Study Start

April 16, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations