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

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

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Hungary

Netherlands

Norway

Portugal

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 26/07/2023

Actual: 26/07/2023

Study start date

Planned: 01/12/2021

Actual: 01/12/2021

Date of final study report

Planned: 30/12/2023

Sources of funding

EMA

Study protocol

Initial protocol

Study Protocol P2 C3-001 Version 3.1 final

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable