CClinicalTrials.gg
CompletedNCT04377035Updated Jun 26, 2023

The Role of Ultrasound in COVID-19

An observational study in COVID-19, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-26.

Sponsored by University Hospital, Gentofte, Copenhagen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
305
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 305 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

In.patients from hospitals of the greater Copenhagen area

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

Exclusion Criteria:

  • Persons not able to cooperate
  • Persons unable to understand and sign "informed consent"
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
305 participants (actual)
Patient registry
No
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What researchers measure

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

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Study locations

1 site
  • Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital
    Hellerup, 2900, Denmark
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References and documents

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. PubMed 36129046 ↗
  • 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. PubMed 35453059 ↗
  • 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. PubMed 34815326 ↗
  • 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. PubMed 34213740 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04377035
Lead sponsor
University Hospital, Gentofte, Copenhagen
Responsible party
Tor Biering-Sørensen (Associate professor and Research Director, Cardiovascular Non-Invasive Imaging Research Laboratory, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
May 6, 2020
Start date
Mar 31, 2020
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021
Last update
Jun 26, 2023

Study contacts

Tor Biering-Sørensen, MD, PhD, MPH
principal investigator · Research Director

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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