The Role of Ultrasound in COVID-19

• ClinicalTrials.gov Identifier: NCT04377035
• Recruitment Status: Unknown
• First Posted: May 6, 2020
• Last Update Posted: November 16, 2020
• Sponsor: University Hospital, Gentofte, Copenhagen
• Information provided by (Responsible Party): Tor Biering-Sørensen, University Hospital, Gentofte, Copenhagen

Tracking Information

• First Submitted Date: May 1, 2020
• First Posted Date: May 6, 2020
• Last Update Posted Date: November 16, 2020
• Actual Study Start Date: March 31, 2020
• Estimated Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 5, 2020)

• In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis [ Time Frame: 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 ]
• Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis [ Time Frame: 2.5 months ]

Original Primary Outcome Measures (submitted: May 1, 2020)

• In-hospital mortality [ Time Frame: 2.5 months ]
  In-hospital mortality for COVID-19
• ARDS (Adult Respiratory Distress Syndrome) ARDS (Adult Respiratory Distress Syndrome) TEMA ARDS (Adult Respiratory Distress Syndrome) TEMA Adult respiratory distress syndrome (ARDS) [ Time Frame: 2.5 months ]
  Incident ARDS (Adult Respiratory Distress Syndrome) during hospitalization for COVID-19 ARDS (Adult Respiratory Distress Syndrome) ARDS (Adult Respiratory Distress Syndrome) Incident ARDS (Adult Respiratory Distress Syndrome) during hospitalization for COVID-19
• Hypoxic respiratory failure [ Time Frame: 2.5 months ]
  Incident hypoxic respiratory failure during hospitalization for COVID-19

Current Secondary Outcome Measures (submitted: May 5, 2020)

• Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis [ Time Frame: 2.5 months ]
• Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis [ Time Frame: 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 ]
• Incident stroke after hospital admission with a confirmed COVID-19 diagnosis at follow-up [ Time Frame: 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 ]
• Incident myocardial infarction after hospital admission with a confirmed COVID-19 diagnosis at follow-up [ Time Frame: 2.5 months to 10 years ]

Original Secondary Outcome Measures (submitted: May 1, 2020)

• Pulmnonary embolism [ Time Frame: 2.5 months ]
  Incident pulmonary embolism during hospitalization for COVID-19
• Cardiac arrest [ Time Frame: 2.5 months ]
  Incident cardiac arrest during hospitalization for COVID-19
• All-cause mortality [ Time Frame: 2.5 months to 10 years ]
  Dearth from any cause at follow-up
• Stroke [ Time Frame: 2.5 months to 10 years ]
  Incident stroke at follow-up
• Heart failure [ Time Frame: 2.5 months to 10 years ]
  Incident heart failure during hospitalization for COVID-19
• Myocardial infarction [ Time Frame: 2.5 months to 10 years ]
  Incident myocardial infarction during hospitalization for COVID-19

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Role of Ultrasound in COVID-19
• Official Title: The ECHOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart and Lung by Ultrasound
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: In.patients from hospitals of the greater Copenhagen area
• Condition: COVID-19
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 1, 2020): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2021
• Estimated Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

Eligibility 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"

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT04377035
• Other Study ID Numbers: H-20021500
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Tor Biering-Sørensen, University Hospital, Gentofte, Copenhagen
• Original Responsible Party: Tor Biering-Sørensen, University Hospital, Gentofte, Copenhagen, MD, PhD, MPH
• Current Study Sponsor: University Hospital, Gentofte, Copenhagen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tor Biering-Sørensen, MD, PhD, MPH; Research Director

• PRS Account: University Hospital, Gentofte, Copenhagen
• Verification Date: November 2020