Registry to study factors that may impact COVID-19 occurrence and severity (CARE)

Study type

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

  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

Study drug and medical condition

• Medical condition to be studied:
  COVID-19

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  35000

Study design details

• Main study objective:
  The objective of this study is to identify factors that may impact the occurrence or severity of COVID-19 infections including examining the role of underlying health conditions, prescription and over-the-counter medications, vitamins and supplements. In the US, comparative COVID vaccine safety and effectiveness is also under study.
• Outcomes:
  Testing positive for COVID-19 and symptom severity, Vaccination for COVID-19
• Data analysis plan:
  Analyses depend on the research question. Analytic plans are developed at the outset of every research question, as they are identified. For vaccine effectiveness, we are using the test-negative control design