USE OF DRUGS ACTING ON RENIN-ANGIOTENSIN SYSTEM (RAS) AND RISK OF COVID-19: A CASE-POPULATION STUDY (SRAA-COVID19)

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:
  Other
• Non-interventional study design, other:
  Case-population study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C03DA) Aldosterone antagonists

  Aldosterone antagonists

  (C09) AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

  AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

  (M01AA) Butylpyrazolidines

  Butylpyrazolidines

  (M01AB) Acetic acid derivatives and related substances

  Acetic acid derivatives and related substances

  (M01AC56) meloxicam, combinations

  meloxicam, combinations

  (M01AE01) ibuprofen

  ibuprofen

  (M01AE02) naproxen

  naproxen

  (M01AG) Fenamates

  Fenamates

  (M01AH) Coxibs

  Coxibs

  (M01AX) Other antiinflammatory and antirheumatic agents, non-steroids

  Other antiinflammatory and antirheumatic agents, non-steroids
• Medical condition to be studied:
  Coronavirus infection
• Additional medical condition(s):
  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)
• Estimated number of subjects:
  11000

Study design details

• Main study objective:
  To assess the association of renin-angiotensin system (RAS) blockers and non-steroidal anti-inflammatory drugs (NSAIDs) with hospital admission due to COVID-19 infection adjusted for age, sex, and cardiovascular risk factors.
• Outcomes:
  - Hospital admission due to COVID-19- Hospital admission to the intensive care unit (ICU) due to COVID-19- In-hospital death after admission due to COVID-19- Admission to ICU or in-hospital death (combined)
• Data analysis plan:
  Main analysis:Crude odds ratios (ORs) and their 95% confidence intervals (CIs) will be computed through univariate conditional logistic regression to assess the association of current use of RAS blockers with the outcome of interest as compared to non-use and as compared to other antihypertensive drugs. After that, we built a multivariate model including the potential confounders (other comorbidities and comedications) all at once. Intermediate analyses: Intermediate analyses will be performed at different points along the study when the number of cases included are: 100, 500 and 750.Sensitivity analysis: Two sources of information from different years will be used (2020 for cases and 2018 for controls). To correct for a secular trend in the prevalence of antihypertensive drugs, we will estimate the prevalence for 2020 and we will obtain a correction factor to adjust the odds ratios for.