ESICM UNITE COVID-19 Project (UNITE-COVID)

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT04836065
• Collaborator: European Society of Intensive Care Medicine (Other)
• Enrollment: 4,995
• Location: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 830.8

Study Details

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	Intervention/Treatment	Phase
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: Jul 1, 2020
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Number of patients admitted with confirmed COVID19 infection [One day with 60 day follow-up]

   Number of patients in the ICU on the study day

2. Mortality (ICU) [One day with 60 day follow-up]

   Proportion of patients who have died at ICU discharge

3. Mortality (60-day) [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 [One day with 60 day follow-up]

   Length of stay in the ICU

2. Proportion of patients requiring invasive mechanical ventilation [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 [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 [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 [One day with 60 day follow-up]

   Proportion of patients who are require a tracheostomy versus all patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Erratum in: JAMA. 2021 May 25;325(20):2120.
• 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.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT04836065
• Other Study ID Numbers: ESICMUNITE2020
• First Posted: Apr 8, 2021
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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: COVID-19

Study Results

No Results Posted as of Apr 8, 2021