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The Role of Ultrasound in COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377035
Recruitment Status : Unknown
Verified November 2020 by Tor Biering-Sørensen, University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
First Posted : May 6, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Tor Biering-Sørensen, University Hospital, Gentofte, Copenhagen

Study Description
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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

Condition or disease
COVID-19

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The ECHOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart and Lung by Ultrasound
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
In.patients from hospitals of the greater Copenhagen area
Criteria

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"
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377035


Contacts
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Contact: Tor Biering-Sørensen, MD, PhD, MPH +4528933590 Tor.Biering-Soerensen@regionh.dk

Locations
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Denmark
Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Tor Biering-sørensen, MD, PhD, MPH         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
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Principal Investigator: Tor Biering-Sørensen, MD, PhD, MPH Research Director
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tor Biering-Sørensen, Associate professor and Research Director, Cardiovascular Non-Invasive Imaging Research Laboratory, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT04377035    
Other Study ID Numbers: H-20021500
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases