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AzTrials

COVID-19 InfectionUNITE-COVIDNCT04836065

ESICM UNITE COVID-19 Project (UNITE-COVID)

An observational study of COVID-19 Infection, run by University Hospital, Ghent at 1 site in Belgium.

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

COVID-19 is arguably the biggest challenge critical care medicine has been confronted with since its conception. Critical care services around the world are flooded by patients presenting with severe respiratory failure who require prolonged treatment in the ICU. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Infection
How many people
4,995 participants
Where
1 siteBelgium
Study dates
1 Jul 2020to 31 Dec 2020
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with confirmed COVID-19 infection present in the ICUs of participating hospitals or in any other place of the hospital under the care of the critical care team on the day between 15th February 2020 and 15th June 2020 with the highest number of COVID-19 patients in the unit or in any other place of the hospital under the care of the critical care team (date to be decided by local investigator).

Who may be able to join

  • Patient is present in an ICU or in any other place of the hospital under the care of the critical care team on the day between 15th February 2020 and 15th June 2020 with the highest number of COVID-19 patients in the unit. The exact date can be decided by the local investigator.
  • COVID-19 confirmed diagnosis through PCR or equivalent diagnostic technique

Who cannot join

  • Any of the following is regarded as a criterion for exclusion from the study: SARS-CoV2 positive without COVID-19

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University Hospital

    Ghent, 9000

Other trials in Belgium

About this study

Official title: European Society Of Intensive Care Medicine COVID-19 Project (UNITE-COVID)

COVID-19 is arguably the biggest challenge critical care medicine has been confronted with since its conception. Critical care services around the world are flooded by patients presenting with severe respiratory failure who require prolonged treatment in the ICU. Despite the support provided, outcomes are poor, particularly in ventilated patients.

Many unanswered questions remain regarding the pathophysiology of COVID-19, particularly in severely ill patients. No evidence-based treatment is currently available, yet different often experimental therapies are administered to patients.

Read more

As experience grows, new phenotypes are recognized, and unreported complications are observed in the most severely ill patients. Although many registries are currently including patients, few of them focus on ICU patients and their specific treatments and newly observed complications and challenges.

Although the pandemic may appear on its return in many countries that are now easing the restrictions that were put in place to limit the spread of the disease, it can be expected that COVID-19 will be a continued challenge in ICUs globally until a safe and effective vaccine is found. Efforts to study the disease should continue in order to advance our understanding of the disease as well as improve treatment options.

Read the detailed description

This is a multicenter, international, anonymized point prevalence study. Patients who were present in the ICU on the day in April 2020 with the highest number of COVID-19 patients in the unit. Data can be entered in the database until July 2020. Retrospective data collection and entry is allowed.

Subjects believed to fulfill all eligibility criteria, and none of the exclusion criteria, detailed in the relevant section of this protocol, will be included in the study.

Data will be entered in the database anonymously.

Data will consist of two core elements:

  1. Center data (to be completed once)
  2. Patient data

For different domains with specific, highly relevant and un(der)explored ICU research questions, an focused data set is to be completed. These domains include:

  1. Respiratory
  2. Coagulation and thrombo-embolic events
  3. Infectious complications
  4. Rehabilitation
  5. Renal
Keywords
Covid-19, Infection, Inflammation, respiratory distress, coagulation, thromboembolus, rehabilitation, renal, cardiac, mobilization
Medical subject headings
COVID-19, Infections, Inflammation, Dyspnea, Thrombosis, Thromboembolism

What is being measured

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

  1. Number of patients admitted with confirmed COVID19 infection

    Number of patients in the ICU on the study day

    Measured: One day with 60 day follow-up

  2. Mortality (ICU)

    Proportion of patients who have died at ICU discharge

    Measured: One day with 60 day follow-up

  3. Mortality (60-day)

    Proportion of patients who have died at day 60

    Measured: One day with 60 day follow-up

Secondary outcomes (5)

  1. Duration of hospitalization in the ICU

    Length of stay in the ICU

    Measured: One day with 60 day follow-up

  2. Proportion of patients requiring invasive mechanical ventilation

    Proportion of patients who require invasive mechanical ventilation during ICU stay versus all patients

    Measured: One day with 60 day follow-up

  3. Proportion of patients developing infections during ICU stay

    Proportion of patients who acquire an infection during their ICU stay versus all patients

    Measured: One day with 60 day follow-up

  4. Proportion of patients developing thromboembolic events during ICU stay

    Proportion of patients who develop any thromboembolic event during their ICU stay versus all patients

    Measured: One day with 60 day follow-up

  5. Proportion of patients requiring tracheotomy during ICU stay

    Proportion of patients who are require a tracheostomy versus all patients

    Measured: One day with 60 day follow-up

Timeline

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

  1. First posted8 Apr 2021
  2. Study start1 Jul 2020
  3. Primary completion30 Sep 2020
  4. Study completion31 Dec 2020

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
4,995 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04836065
Sponsor's protocol ID
ESICMUNITE2020
Acronym
UNITE-COVID
Status last verified
Apr 2021
First submitted
25 Jun 2020
Last updated
8 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lodigiani C, Iapichino G, Carenzo L, Cecconi M, Ferrazzi P, Sebastian T, Kucher N, Studt JD, Sacco C, Bertuzzi A, Sandri MT, Barco S; Humanitas COVID-19 Task Force. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020 Jul;191:9-14. doi: 10.1016/j.thromres.2020.04.024. Epub 2020 Apr 23.

    PubMed 32353746

  • Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.

    PubMed 32222812

  • Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available.

    PubMed 32167538

  • Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

    PubMed 32250385

  • Kloss P, Lindholz M, Milnik A, Azoulay E, Cecconi M, Citerio G, De Corte T, Duska F, Galarza L, Greco M, Girbes ARJ, Kesecioglu J, Mellinghoff J, Ostermann M, Pellegrini M, Teboul JL, De Waele J, Wong A, Schaller SJ; ESICM UNITE COVID Investigators. Early mobilisation in critically ill COVID-19 patients: a subanalysis of the ESICM-initiated UNITE-COVID observational study. Ann Intensive Care. 2023 Nov 14;13(1):112. doi: 10.1186/s13613-023-01201-1.

    PubMed 37962748

  • Conway Morris A, Kohler K, De Corte T, Ercole A, De Grooth HJ, Elbers PWG, Povoa P, Morais R, Koulenti D, Jog S, Nielsen N, Jubb A, Cecconi M, De Waele J; ESICM UNITE COVID investigators. Co-infection and ICU-acquired infection in COIVD-19 ICU patients: a secondary analysis of the UNITE-COVID data set. Crit Care. 2022 Aug 3;26(1):236. doi: 10.1186/s13054-022-04108-8.

    PubMed 35922860

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Infection, run by University Hospital, Ghent at 1 site in Belgium.

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 2 inclusion and 1 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 8 Apr 2021. 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 Belgium. 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?

Number of patients admitted with confirmed COVID19 infection (time frame: One day with 60 day follow-up). 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 NCT04836065, which also lists 6 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 8 Apr 2021.

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