- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04377035
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
- Olsen FJ, Lassen MCH, Skaarup KG, Christensen J, Davidovski FS, Alhakak AS, Sengelov M, Nielsen AB, Johansen ND, Graff C, Bundgaard H, Hassager C, Jabbari R, Carlsen J, Kirk O, Lindholm MG, Wiese L, Kristiansen OP, Nielsen OW, Lindegaard B, Tonder N, Ulrik CS, Lamberts M, Sivapalan P, Gislason G, Iversen K, Jensen JUS, Schou M, Svendsen JH, Aalen JM, Smiseth OA, Remme EW, Biering-Sorensen T. Myocardial Work in Patients Hospitalized With COVID-19: Relation to Biomarkers, COVID-19 Severity, and All-Cause Mortality. J Am Heart Assoc. 2022 Oct 4;11(19):e026571. doi: 10.1161/JAHA.122.026571. Epub 2022 Sep 21.
- Espersen C, Platz E, Alhakak AS, Sengelov M, Simonsen JO, Johansen ND, Davidovski FS, Christensen J, Bundgaard H, Hassager C, Jabbari R, Carlsen J, Kirk O, Lindholm MG, Kristiansen OP, Nielsen OW, Jeschke KN, Ulrik CS, Sivapalan P, Iversen K, Staehr Jensen JU, Schou M, Skaarup SH, Hojbjerg Lassen MC, Skaarup KG, Biering-Sorensen T. Lung ultrasound findings following COVID-19 hospitalization: A prospective longitudinal cohort study. Respir Med. 2022 Jun;197:106826. doi: 10.1016/j.rmed.2022.106826. Epub 2022 Apr 2.
- Skaarup KG, Lassen MCH, Espersen C, Lind JN, Johansen ND, Sengelov M, Alhakak AS, Nielsen AB, Ravnkilde K, Hauser R, Schops LB, Holt E, Bundgaard H, Hassager C, Jabbari R, Carlsen J, Kirk O, Bodtger U, Lindholm MG, Wiese L, Kristiansen OP, Walsted ES, Nielsen OW, Lindegaard B, Tonder N, Jeschke KN, Ulrik CS, Lamberts M, Sivapalan P, Pallisgaard J, Gislason G, Iversen K, Jensen JUS, Schou M, Skaarup SH, Platz E, Biering-Sorensen T. Lung ultrasound findings in hospitalized COVID-19 patients in relation to venous thromboembolic events: the ECHOVID-19 study. J Ultrasound. 2022 Sep;25(3):457-467. doi: 10.1007/s40477-021-00605-8. Epub 2021 Jul 2.
- Espersen C, Platz E, Skaarup KG, Lassen MCH, Lind JN, Johansen ND, Sengelov M, Alhakak AS, Nielsen AB, Bundgaard H, Hassager C, Jabbari R, Carlsen J, Kirk O, Lindholm MG, Kristiansen OP, Nielsen OW, Jeschke KN, Ulrik CS, Sivapalan P, Gislason G, Iversen K, Jensen JUS, Schou M, Skaarup SH, Biering-Sorensen T. Lung Ultrasound Findings Associated With COVID-19 ARDS, ICU Admission, and All-Cause Mortality. Respir Care. 2022 Jan;67(1):66-75. doi: 10.4187/respcare.09108. Epub 2021 Nov 23.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-20021500
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.