Effect of drug consumption before and during the SARS-COV-2 infection on the evolution of patients with COVID-19. A population-based study (COVIDrug)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01A) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS

  (C09A) ACE INHIBITORS, PLAIN

  ACE INHIBITORS, PLAIN

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

  ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  (M01A) ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS

  ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
• Medical condition to be studied:
  Hospitalisation

  Nosocomial infection
• Additional medical condition(s):
  ICU admision,Mortality

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)
• Estimated number of subjects:
  75000

Study design details

• Main study objective:
  Assess whether prior consumption of certain medications (ACEIs, ARBs, ibuprofen…) conditions a greater susceptibility to infection by SARS-COV-2
• Outcomes:
  Hospitalization by COVID-19
• Data analysis plan:
  Multilevel logistic regression analysis will be performed, considering each stratum (a case and the controls with the matching variables) as an aggregation unit to estimate the odds ratio, and its 95% confidence interval (CI) for the risk of Covid- 19 associated with exposures of interest. Adjustments will be made for the above-reported covariates. Odds ratio trends will be tested, when feasible, according to the statistical significance of the regression coefficient of the recoded variable obtained by scoring the corresponding categories. Crude and adjusted estimates will be obtained for the effect of different therapies dispensed compared with the absence of any drug therapy.