Study identification

PURI

https://redirect.ema.europa.eu/resource/38561

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 institution and networks

Institutions

Contact details

Henrik Toft Sørensen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Aarhus University
Study protocol
Initial protocol

Protocol ACEi-ARB COVID-19 EU PAS

English (773.31 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable