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

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.

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 4995

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients admitted with confirmed COVID19 infection	Number of patients in the ICU on the study day	One day with 60 day follow-up
Mortality (ICU)	Proportion of patients who have died at ICU discharge	One day with 60 day follow-up
Mortality (60-day)	Proportion of patients who have died at day 60	One day with 60 day follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization in the ICU	Length of stay in the ICU	One day with 60 day follow-up
Proportion of patients requiring invasive mechanical ventilation	Proportion of patients who require invasive mechanical ventilation during ICU stay versus all patients	One day with 60 day follow-up
Proportion of patients developing infections during ICU stay	Proportion of patients who acquire an infection during their ICU stay versus all patients	One day with 60 day follow-up
Proportion of patients developing thromboembolic events during ICU stay	Proportion of patients who develop any thromboembolic event during their ICU stay versus all patients	One day with 60 day follow-up
Proportion of patients requiring tracheotomy during ICU stay	Proportion of patients who are require a tracheostomy versus all patients	One day with 60 day follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: European Society of Intensive Care Medicine
• Investigators: Principal Investigator: Jan DE WAELE, University of Gent Hospital

Publications and helpful links

General Publications

• 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. Erratum In: JAMA. 2021 May 25;325(20):2120.
• 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.
• 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.
• 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.
• 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. Erratum In: Crit Care. 2022 Aug 17;26(1):249.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Infection; renal; rehabilitation; Covid-19; respiratory distress; cardiac; coagulation; mobilization; thromboembolus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ESICMUNITE2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No