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ESICM UNITE COVID-19 Project (UNITE-COVID)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04836065
Acronym
UNITE-COVID
Enrollment
4995
Registered
2021-04-08
Start date
2020-07-01
Completion date
2020-12-31
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Infection

Keywords

Covid-19, Infection, Inflammation, respiratory distress, coagulation, thromboembolus, rehabilitation, renal, cardiac, mobilization

Brief 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. 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. 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.

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

Interventions

None listed

Sponsors

University Hospital, Ghent
Lead SponsorOTHER
European Society of Intensive Care Medicine
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients admitted with confirmed COVID19 infectionOne day with 60 day follow-upNumber of patients in the ICU on the study day
Mortality (ICU)One day with 60 day follow-upProportion of patients who have died at ICU discharge
Mortality (60-day)One day with 60 day follow-upProportion of patients who have died at day 60

Secondary

MeasureTime frameDescription
Proportion of patients developing thromboembolic events during ICU stayOne day with 60 day follow-upProportion of patients who develop any thromboembolic event during their ICU stay versus all patients
Duration of hospitalization in the ICUOne day with 60 day follow-upLength of stay in the ICU
Proportion of patients requiring tracheotomy during ICU stayOne day with 60 day follow-upProportion of patients who are require a tracheostomy versus all patients
Proportion of patients requiring invasive mechanical ventilationOne day with 60 day follow-upProportion of patients who require invasive mechanical ventilation during ICU stay versus all patients
Proportion of patients developing infections during ICU stayOne day with 60 day follow-upProportion of patients who acquire an infection during their ICU stay versus all patients

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026