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OpenTrials
Completed

NCT Number: NCT04377035

The Role of Ultrasound in COVID-19

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Primary outcomes

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

    Time frame: 2.5 months

  2. Incident ARDS (Adult Respiratory Distress Syndrome) and intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis

    Time frame: 2.5 months

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

    Time frame: 2.5 months

Secondary outcomes

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

    Time frame: 2.5 months

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

    Time frame: 2.5 months

  3. Death from any cause after hospital admission with a confirmed COVID-19 diagnosis at follow-up

    Time frame: 2.5 months to 10 years

  4. Incident stroke after hospital admission with a confirmed COVID-19 diagnosis at follow-up

    Time frame: 2.5 months to 10 years

  5. Incident heart failure after hospital admission with a confirmed COVID-19 diagnosis at follow-up

    Time frame: 2.5 months to 10 years

  6. Incident myocardial infarction after hospital admission with a confirmed COVID-19 diagnosis at follow-up

    Time frame: 2.5 months to 10 years

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 6, 2020
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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