ESICM UNITE COVID-19 Project (UNITE-COVID)

Completed

• Conditions: COVID-19 Infection

• Registration Number: NCT04836065
• Lead Sponsor: University Hospital, Ghent

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

Study Timeline

• Study First Submitted: 2020-06-25
• Study Start: 2020-07-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-06
• Last Update Submitted: 2021-04-06
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4995

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Mortality (ICU)	One day with 60 day follow-up	Proportion of patients who have died at ICU discharge
Mortality (60-day)	One day with 60 day follow-up	Proportion of patients who have died at day 60

Secondary Outcome Measures

Name	Time	Method
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
Duration of hospitalization in the ICU	One day with 60 day follow-up	Length of stay in the ICU
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
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
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

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium