ESICM UNITE COVID-19 Project (UNITE-COVID)

COVID-19 Infection Clinical Trial

— UNITE-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836065
• Other study ID #: ESICMUNITE2020
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4995
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Infection
• Infection

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	European Society of Intensive Care Medicine

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mortality (ICU)	Proportion of patients who have died at ICU discharge	One day with 60 day follow-up
Primary	Mortality (60-day)	Proportion of patients who have died at day 60	One day with 60 day follow-up
Secondary	Duration of hospitalization in the ICU	Length of stay in the ICU	One day with 60 day follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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