Association of ACE inhibitors and AT1R blockers and prognosis in hospitalized COVID-19 patients: a cohort study in Italy (ITA-COVID: RAS INHIBITORS)

Study type

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

  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C09) AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

  AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Population studied

• Short description of the study population:
  A cohort study will be conducted in several Italian regions and local health units (LHU). All patients aged 18 years and older who are hospitalized for a COVID-19 confirmed diagnosis will be included.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  COVID-19 patients
• Estimated number of subjects:
  21000000

Study design details

• Main study objective:
  The aim of this study is to verify if the use of ACE inhibitors and/or angiotensin receptor blockers before COVID-19 outbreak may modify the clinical course of infection and prognosis of hospitalized SARS-CoV-2 infected patients in Italy.
• Outcomes:
  Death, intensive care unit (ICU) admission, and length of ICU stay.
• Data analysis plan:
  Data will be described using frequencies, percentage, mean with standard deviations (or median with interquartile range, where appropriate). The association between ACE inhibitors and/or AT1R blockers and the study outcomes will be analyzed.