An Assessment of a relationship between the exposure to COVID-19 vaccines and risk of thrombotic thrombocytopenia syndrome (Association of the risk for Thrombotic Thrombocytopenia Syndrome and Exposure To COVID-19 vaccines) - ATTEST study

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Study drug and medical condition

• Name of medicine, other:
  Vaxzevria; COVID-19 Vaccine (ChAdOx1-S [recombinant]);
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN02) covid-19, viral vector, non-replicating

  covid-19, viral vector, non-replicating
• Medical condition to be studied:
  COVID-19 immunisation

  COVID-19
• Additional medical condition(s):
  COVID-19 vaccination/SARS-CoV-2 infection

Population studied

• Age groups:
  • 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  25428392

Study design details

• Main study objective:
  To evaluate an association between COVID-19 vaccine exposure and thromboembolic events occurring with thrombocytopenia (thrombotic thrombocytopenia syndrome, TTS).
• Outcomes:
  Thrombotic thrombocytopenia syndrome, TTS
• Data analysis plan:
  A detailed Statistical Analysis Plan (SAP) will be developed for this analysis. The SAP may modify the plans outlined in the protocol, any major modifications of primary endpoint definitions or their analyses would be reflected in a protocol amendment. All statistical analyses will use the R statistical software.