EHDS2 Pilot Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 during the Omicron period.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107316
• EU PAS number:
  EUPAS107315
• Study ID:
  107316
• Official title and acronym:
  EHDS2 Pilot Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 during the Omicron period.
• DARWIN EU® study:
  No
• Study countries:
  Croatia

  Denmark

  Estonia

  Finland

  France

  Netherlands

  Spain

  United Kingdom
• Study description:
  HealthData@EU is the European Health Data Space (EHDS) Pilot project that aims to investigate and establish an infrastructure and data ecosystem for the secondary use of health data for research, innovation and better policy making in Europe. The proposed study is one of the five use cases selected to test and inform HealthData@EU frameworks. The aim of the study is to contextualise the risk of venous and arterial thromboembolic events associated with COVID-19, during the period when Omicron dominant, in light of past COVID-19 infection and SARS-CoV-2 vaccination. This will be performed in a federated manner through multiple international databases to inform the HealthData@EU project.
• Study status:
  Ongoing

Research institution and networks

Institutions

European Medicines Agency (EMA)

Pharmaco- and Device epidemiology, University of Oxford

United Kingdom (Northern Ireland)

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 30/09/2022

Actual: 30/09/2022

Study start date

Planned: 01/05/2023

Actual: 01/05/2023

Date of final study report

Planned: 24/10/2023

Sources of funding

EU institutional research programme

More details on funding

EU Commission

Study protocol

Initial protocol

EHDS-Coagulopathy-protocol_EHDS2

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable