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

Study identification

• EU PAS number:
  EUPAS34887
• Study ID:
  38561
• Official title and acronym:
  Renin-angiotensin-aldosterone system inhibitors and adverse outcomes of COVID-19: a Danish nationwide cohort study (ACE-I/ARB and COVID-19)
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  Speculations suggest that use of ACE-I/ARB may increase the risk of developing severe or fatal COVID-19 by upregulating expression of the ACE2 enzyme. The European Medicines Agency, and other major institutions and societies, have called for research and issued warnings against ACE-I/ARB discontinuation in patients with COVID-19, as drug discontinuation may worsen underlying cardiometabolic conditions. As ACE-I/ARB are widely used drugs, any association with risk and prognosis may have public health impact. Thus, there is an urgent need to clarify the hypothesis of any increased risk for COVID-19 or worsened prognosis for adverse outcomes of COVID-19. The primary aim of the study is to examine the association between ACE-I/ARB use and risk of death in patients with COVID-19. The secondary aim is to examine the association of ACE-I/ARB use with risk of hospital admission, ICU admission, mechanical ventilation, and renal replacement therapy. The third aim is to examine the risk of being diagnosed with COVID-19 among all patients referred to SARS-CoV-2 testing. This nationwide study will include all patients tested for SARS-CoV-2 in Denmark. By individual-level linkage of Danish registries, the impact of ACE-I/ARB on risk of COVID-19 will be examined using a test-negative case-control design, while the prognosis with regard to mortality and intensive care admission will be examined in a cohort design of test-positive COVID-19 patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Aarhus University & Aarhus University Hospital CLINICAL EPIDEMIOLOGY AND DATA SCIENCE, DEPARTMENT OF CLINICAL MEDICINE

Denmark

Pharmacoepi center, University of Southern Denmark

Denmark

Study timelines

Date when funding contract was signed

Planned:22/04/2020

Actual:22/04/2020

Study start date

Planned:27/02/2020

Actual:27/02/2020

Data analysis start date

Planned:27/04/2020

Date of final study report

Planned:01/06/2020

Actual:09/12/2020

Sources of funding

Other

More details on funding

Aarhus University

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable