The Role of Ultrasound in COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04377035
• Other study ID #: H-20021500
• Status: Completed
• Start date: March 31, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2023
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Denmark	Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis		2.5 months
Primary	Incident ARDS (Adult Respiratory Distress Syndrome) and intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis		2.5 months
Primary	Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis		2.5 months
Secondary	Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis		2.5 months
Secondary	Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis		2.5 months
Secondary	Death from any cause after hospital admission with a confirmed COVID-19 diagnosis at follow-up		2.5 months to 10 years
Secondary	Incident stroke after hospital admission with a confirmed COVID-19 diagnosis at follow-up		2.5 months to 10 years
Secondary	Incident heart failure after hospital admission with a confirmed COVID-19 diagnosis at follow-up		2.5 months to 10 years
Secondary	Incident myocardial infarction after hospital admission with a confirmed COVID-19 diagnosis at follow-up		2.5 months to 10 years