Association between renin-angiotensin-aldosterone system (RAAS) inhibitors and severe outcomes among patients exposed with SARS-COV2: a retrospective analysis using administrative databases in North Italy (COVID-19) (RAAS-COVID19-BG-BS)

Study type

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

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

  (C09A) ACE INHIBITORS, PLAIN

  ACE INHIBITORS, PLAIN

  (C09B) ACE INHIBITORS, COMBINATIONS

  ACE INHIBITORS, COMBINATIONS

  (C09C) ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  (C09DX) Angiotensin II receptor blockers (ARBs), other combinations

  Angiotensin II receptor blockers (ARBs), other combinations

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)
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  The primary aim of this analysis is to investigate the association between use of RAAS inhibitors and severe outcomes (i.e. death, admission in ICU) among hospitalized patients with confirmed COVID-19.
• Outcomes:
  Death, admission in ICU, Demographic and clinical characteristics (including drug exposure patterns) on patients population by study outcomes
• Data analysis plan:
  Descriptive statistics, standard cumulative hazard estimates, and multivariate Cox proportional hazards regression analyses.