Status: Ongoing First registered on: 03/10/2023
Last updated on: 23/10/2023
1. Study identification
EU PAS Register NumberEUPAS106679
Official titleDARWIN EU® CC - EHDS Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 in the context of the OMICRON variant
Study title acronym
Study typeObservational study
Brief description of the studyThe aim of the study is to contextualize the risk of venous and arterial thromboembolic events associated with COVID-19, during the Omicron period, and SARS-CoV-2 vaccination. The research objectives which will be addressed incrementally to support the project aim are to estimate the background incidence rate of venous and arterial thromboembolic events among the general pre-pandemic population, to estimate the incidence rate of venous and arterial thromboembolic events among patients with COVID-19 within 30-, 60-, and 90- and 180-days during the Omicron period, stratified by prior SARS-CoV-2 vaccination and prior infection status, to estimate the incidence rate of venous and arterial thromboembolic events among patients with SARS-CoV-2 vaccination within 30-, 60-, 90- and 180-days, stratified by prior infection status, to estimate the association between clinical risk factors including prior SARS-CoV-2 vaccination on the incidence rate of venous and arterial events among patients with COVID-19 and the impact that thromboembolic events have on worsening severity of COVID-19 during the Omicron period and to estimate incidence rate ratios for venous and arterial thromboembolic events among patients with COVID-19 and people vaccinated against SARS-CoV-2, compared to the background population using incidence rates estimated in objectives 1 to 3.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameDARWIN EU® CC
Centre locationRotterdam, Netherlands
Details of (Primary) lead investigator
Title Dr
Last name Catala Sabate
First name Marti
Is this study being carried out with the collaboration of a research network?
Yes

DARWIN EU CC
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

IDIAPJGol
IQVIA
University of Tartu, Estonia
Erasmus MC, Netherlands
University of Oxford, United Kingdom
Countries in which this study is being conducted
International study

Estonia
Germany
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed26/07/202326/07/2023
Start date of data collection01/12/202101/12/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report30/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Catala Sabate
First name Marti
Address line 1University of Oxford
Address line 2Windmill Road 
Address line 3 
CityOxford 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)441865223725 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org
Public Enquiries
Title Mrs 
Last name Schuemie 
First name Ilse 
Address line 1Dr Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org 
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