Study identification

PURI

https://redirect.ema.europa.eu/resource/107276

EU PAS number

EUPAS106679

Study ID

107276

Official title and acronym

DARWIN EU® 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

DARWIN EU® study

Yes

Study countries

Estonia
Germany
Netherlands
Spain
United Kingdom

Study description

The 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.

Study status

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Marti Catala Sabate

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol
English (994.09 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable