The Role of Ultrasound in COVID-19

Completed

• Conditions: COVID-19

• Registration Number: NCT04377035
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-31
• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-06
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital; 🇩🇰 Hellerup, Denmark