Renin-angiotensin-aldosterone system inhibitors and adverse outcomes of COVID-19: a Danish nationwide cohort study (ACE-I/ARB and COVID-19)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C09A) ACE INHIBITORS, PLAIN

  (C09B) ACE INHIBITORS, COMBINATIONS

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

  (C09D) ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
• Medical condition to be studied:
  COVID-19

Population studied

• Short description of the study population:
  The source population is all Danish citizens (popuation~5.8 million). The study population for risk analysis (the test-negative case-control analysis) will be all patients tested for SARS-CoV-2, while the prognosis analysis (cohort analysis) will only include patients tested positive SARS-CoV-2, i.e., patients with COVID-19.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  7515

Study design details

• Main study objective:
  To examine the association between ACE-I/ARB use and adverse outcomse of COVID-19.
• Outcomes:
  Death within 30 days after positive test for SARS-CoV-2. Hospital admission at day of or within 30 days after a positive test for SARS-CoV-2.Intensive care unit admission, mechanical ventilation, and renal replacement therapy at dayof or within 30 days after positive test for SARS-CoV-2.Positive tests among all patients tested for SARS-CoV-2.
• Data analysis plan:
  Propensity-score weighted risk, risk difference and risk ratio for the outcomes.Adjusted odds ratio for positive test among all tested.

Documents

Study publications

Christiansen CF, Pottegård A, Heide-Jørgensen U, Bodilsen J, Søgaard OS, Maeng …