Status: Finalised First registered on: 27/04/2020
Last updated on: 10/12/2020
1. Study identification
EU PAS Register NumberEUPAS34887
Official titleRenin-angiotensin-aldosterone system inhibitors and adverse outcomes of COVID-19: a Danish nationwide cohort study
Study title acronymACE-I/ARB and COVID-19
Study typeObservational study
Brief description of the studySpeculations 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.
Was this study requested by a regulator?Yes: Denmark
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsAarhus University Dept. of Clinical Epidemiology
Department/Research groupAarhus University, Department of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Website/Homepagewww.kea.au.dk
Details of (Primary) lead investigator
Title Professor
Last name Sørensen
First name Henrik Toft
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

University of Southern Denmark Pharmacoepi center
Countries in which this study is being conducted
National study

Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed22/04/202022/04/2020
Start date of data collection27/02/202027/02/2020
Start date of data analysis27/04/2020
Date of interim report, if expected
Date of final study report01/06/202009/12/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherAarhus University100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Toft Sørensen
First name Henrik
Address line 1Department of Clinical Epidemiology, Aarhus University Hospital
Address line 2Olof Palmes Alle 43-45 
Address line 3 
CityAarhus N 
Postcode8200 
CountryDenmark
Phone number (incl. country code)45-87168063 
Alternative phone number45-87167212 
Fax number (incl. country code) 
Email address hts@clin.au.dk
Public Enquiries
Title Dr 
Last name Christiansen 
First name Christian Fynbo 
Address line 1Department of Clinical Epidemiology, Aarhus University Hospital 
Address line 2Olof Palmes Alle 43-45 
Address line 3 
CityAarhus N 
Postcode8200 
CountryDenmark 
Phone number (incl. country code)45-87168218 
Alternative phone number45-87167212 
Fax number (incl. country code) 
Email address cfc@clin.au.dk 
Top