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

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN) Covid-19 vaccines

  Covid-19 vaccines

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  30000000

Study design details

• Main study objective:
  The aim of the study is to contextualise the risk of venous and arterial thromboembolic events associated with COVID-19, during the Omicron period when Omicron, and SARS-CoV-2 vaccination.
• Outcomes:
  Venous and arterial thromboembolic events, Worsening COVID-19 disease progression
• Data analysis plan:
  Descriptive analysis Cause-specific Cox models to examine risk factors associated with thromboembolic events in patients with COVID-19 Crude and standardized incidence rate ratios (SIRs) for thromboembolic events in each cohort of interest.