The Role of Ultrasound in COVID-19

June 23, 2023 updated by: Tor Biering-Sørensen, University Hospital, Gentofte, Copenhagen

The ECHOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart and Lung by Ultrasound

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 echocardiography - both conventional and advanced - can be used to predict which patients will develop acute respiratory distress syndrome (ARDS) or other short-term acute complications, especially focusing on cardiovascular outcomes. In addition, using a novel technique of lung ultrasound (LUS), The investigators aim to analyze specific LUS-findings, and associate them with short-term prognosis and development of ARDS and long-term cardiovascular morbidity and mortality. In all patients included, The investigators aim to examine long-term complications at timepoints: 2, 5 and 10 years of follow-up and examine if echocardiography - 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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hellerup, Denmark, 2900
        • Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

In.patients from hospitals of the greater Copenhagen area

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 2.5 months
2.5 months
Incident ARDS (Adult Respiratory Distress Syndrome) and intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 2.5 months
2.5 months
Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 2.5 months
2.5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 2.5 months
2.5 months
Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 2.5 months
2.5 months
Death from any cause after hospital admission with a confirmed COVID-19 diagnosis at follow-up
Time Frame: 2.5 months to 10 years
2.5 months to 10 years
Incident stroke after hospital admission with a confirmed COVID-19 diagnosis at follow-up
Time Frame: 2.5 months to 10 years
2.5 months to 10 years
Incident heart failure after hospital admission with a confirmed COVID-19 diagnosis at follow-up
Time Frame: 2.5 months to 10 years
2.5 months to 10 years
Incident myocardial infarction after hospital admission with a confirmed COVID-19 diagnosis at follow-up
Time Frame: 2.5 months to 10 years
2.5 months to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tor Biering-Sørensen, MD, PhD, MPH, Research Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

May 1, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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