The EUROPEAN SOCIETY OF INTENSIVE CARE MEDICINE COVID-19 Project (UNITE-COVID)

What?

UNITE-COVID is an observational, multicenter, international point prevalence study.

Aims?

This study will provide answers to the following questions from a global perspective:

What is the burden of COVID-19 in ICUs around the world?
How are patients with COVID-19 now managed around the world?
What are the outcomes of ICU patients with COVID-19?
What is the incidence of specific patterns such as respiratory phenotypes, AKI, infectious complications, thromboembolic events (venous and arterial), neurological complications and cardiac complications

Why?

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.

Design

This is a multicenter, international, anonymized point prevalence study.

Patients who were present in the ICU on the day between February 15th and June 15th 2020 with the highest number of COVID-19 patients in the unit. Data can be entered in the database until  August 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: Center data (to be completed once) and Patient data

For different domains with specific, highly relevant and un(der)explored ICU research questions, a focused data set is to be completed. These domains include:

Respiratory (group lead: Giacomo Grasselli)
Coagulation and thrombo-embolic events (group lead: Andrea Liviano)
Infectious complications (group lead Andy Conway Morris)
Rehabilitation (group lead Stefan Schaller)
Renal  (group lead Marlies Ostermann)

We will collect data in all countries, academic and non-academic ICUs, and on heterogeneous populations of critically ill patients.

Patient Population: Critically ill patients diagnosed with COVID-19 present in the ICU or any other area in the hospital under the care of  the critical care team on the day between February 15 and June 15th, 2020 with the highest number of COVID-19 patients in the unit.

When?

Select the day between February 15th and June 15th, 2020 with the highest number of criticaly-ill Covid-19 patients in the unit or in any other area in the hospital under the care of  the critical care team

Study duration: 1 day (with 60 day follow up)

What data is required?

Inclusion criteria: For inclusion in the study, subjects must fulfill all of the following criteria:

Age 18 or older

Patient is present in an ICU or any other area in the hospital under the care of the critical care team on the day between February 15th and June 15th 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.

Data Collection:

For each participating center we will collect center data as detailed in CenterData CRF.

Data will be recorded regarding current nurse/patient ratio, MD/patient ratio,number of beds, 24h intensivist staffing, and hospital type, as well as resources available and capacity.

This will be completed only once per center. Data entry will be facilitated by an electronic Case Report Form (eCRF). No patient identifying information will be collected.

Do I need IRB approval?

Where required by local legislation or regulation, the study protocol will be submitted to the local ethics committee for approval.  Whereas UNITE-COVID-19 is a retrospective no-risk study, a waived informed consent model can be used. Please find the Principal Investigator’s Ethical Approval (Belgium) here

How is the data that is collected managed?

Access to the database is protected via a TLS encrypted connection and a login/password combination. The data will be stored securely and all procedures regarding data management will comply with General Data Protection Regulation (GDPR) 2016/679/EU. The eCRF platform is licensed from ClinFile and administered by ESICM.

The eCRF platform is GDPR compliant.

Who owns and can access the collected data? 

Each site investigator is responsible for their own data, and may request an export of their locally collected data after the UNITE-COVID-19 database is locked. The request should be addressed to the Principal Investigator.
After the primary UNITE-COVID-19 manuscript is published, investigators may publish their local data.

Authorship and publication rules: Steering Committee members will be part of the writing committee and listed as authors of the final manuscript. The Unite Covid Steering Committee decided to revise  how best to acknowledge the collaborators in order to appropriately thank  you and your team for your efforts. Any center that has obtained ethics committee approval (if necessary according to local regulations) and that included at least 2 patients can have 1 collaborator mentioned in the list of collaborators attached to the publication of the primary paper. In case more cases are included the following applies: 20 or more patients: 2 collaborators; 50 or more patients: 3 collaborators; 100 or more patients: 4 collaborators

Is there any financial compensation?

There is no financial compensation for participation. Participation in the trial is completely voluntary.

How do I participate?

Registration is closed.

UNITE-COVID-19 Steering Committee Members

list available soon

Any further Questions?

Please read Frequently Asked Questions (FAQs) document.

You can contact the ESICM office: research@esicm.org or guy.francois@esicm.org

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