ESICM UNITE COVID-19 Project (UNITE-COVID) (UNITE-COVID)

• ClinicalTrials.gov Identifier: NCT04836065
• Recruitment Status: Completed
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Sponsor: University Hospital, Ghent
• Collaborator: European Society of Intensive Care Medicine
• Information provided by (Responsible Party): University Hospital, Ghent

Study Description

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.

Condition or disease
COVID-19 Infection

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

Study Design

• Study Type: Observational
• Actual Enrollment: 4995 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: European Society Of Intensive Care Medicine COVID-19 Project (UNITE-COVID)
• Actual Study Start Date: July 1, 2020
• Actual Primary Completion Date: September 30, 2020
• Actual Study Completion Date: December 31, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Number of patients admitted with confirmed COVID19 infection [ Time Frame: One day with 60 day follow-up ]
   Number of patients in the ICU on the study day
2. Mortality (ICU) [ Time Frame: One day with 60 day follow-up ]
   Proportion of patients who have died at ICU discharge
3. Mortality (60-day) [ Time Frame: One day with 60 day follow-up ]
   Proportion of patients who have died at day 60

Secondary Outcome Measures :

1. Duration of hospitalization in the ICU [ Time Frame: One day with 60 day follow-up ]
   Length of stay in the ICU
2. Proportion of patients requiring invasive mechanical ventilation [ Time Frame: One day with 60 day follow-up ]
   Proportion of patients who require invasive mechanical ventilation during ICU stay versus all patients
3. Proportion of patients developing infections during ICU stay [ Time Frame: One day with 60 day follow-up ]
   Proportion of patients who acquire an infection during their ICU stay versus all patients
4. Proportion of patients developing thromboembolic events during ICU stay [ Time Frame: One day with 60 day follow-up ]
   Proportion of patients who develop any thromboembolic event during their ICU stay versus all patients
5. Proportion of patients requiring tracheotomy during ICU stay [ Time Frame: One day with 60 day follow-up ]
   Proportion of patients who are require a tracheostomy versus all patients

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

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).

Criteria

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

Contacts and Locations

Locations

Belgium

Ghent University Hospital

Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

European Society of Intensive Care Medicine

Investigators

• Principal Investigator: Jan DE WAELE; University of Gent Hospital

More Information

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.

Alhazzani W, Møller 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.

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.

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.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT04836065
• Other Study ID Numbers: ESICMUNITE2020
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by University Hospital, Ghent:

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

Additional relevant MeSH terms:

Infection