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COVID-19NCT04377035

The Role of Ultrasound in COVID-19

An observational study of COVID-19, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
How many people
305 participants
Where
1 siteDenmark
Study dates
31 Mar 2020to 1 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: In.patients from hospitals of the greater Copenhagen area

Who may be able to join

  • All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 > 18 years of age.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

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

    Hellerup, 2900

Other trials in Denmark

About this study

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

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

Conditions
COVID-19
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2.5 months

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

    Measured: 2.5 months

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

    Measured: 2.5 months

Secondary outcomes (6)

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

    Measured: 2.5 months

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

    Measured: 2.5 months

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

    Measured: 2.5 months to 10 years

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

    Measured: 2.5 months to 10 years

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

    Measured: 2.5 months to 10 years

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

    Measured: 2.5 months to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2020
  2. Study start31 Mar 2020
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04377035
Sponsor's protocol ID
H-20021500
Status last verified
Jun 2023
First submitted
1 May 2020
Last updated
26 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wodschow HZ, Davidovski FS, Christensen J, Lassen MCH, Skaarup KG, Nygaard H, Moller N, Rungby J, Biering-Sorensen T, Rossing P, Jensen NJ, Laursen JC. Oral ketone esters acutely improve myocardial contractility in post-hospitalized COVID-19 patients: A randomized placebo-controlled double-blind crossover study. Front Nutr. 2023 Feb 9;10:1131192. doi: 10.3389/fnut.2023.1131192. eCollection 2023.

    PubMed 36845050

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis (time frame: 2.5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04377035, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.

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