Official Title
Stopping ACE-inhibitors in COVID-19: A Randomized Controlled Trial
Brief Summary

ACEI-COVID-19 is a multicenter, randomized trial testing the hypothesis that stopping/replacing chronic treatment with ACE-inhibitors (ACEI) or angiotensin receptor blockers (ARB) improves outcomes in symptomatic SARS-CoV2-infected patients

Detailed Description

The COVID-19 pandemic currently poses unprecedented challenges to the health systems of all
countries. Experimental studies show that the SARS-CoV2 virus enters human cells via the
angiotensin converting enzyme II receptor 2 (ACE2). ACE inhibitors (ACEI) and angiotensin
receptor blockers (ARB) can lead to an increase in the expression of ACE2. Therefore, there
is concern that in patients treated with ACEI or ARB, the absorption of the virus is
facilitated, thereby accelerating its spread in the body.

ACEI-COVID tests the hypothesis that stopping chronic ACEI / ARB therapy in
SARS-CoV2-infected patients improves outcomes.

Completed
SARS-CoV-2
COVID-19

Drug: ACE inhibitor, angiotensin receptor blocker

In patients randomized to stopping / replacing ACEI or ARB, it may be necessary to switch to another drug without direct effect on the RAS system. In patients, randomized to continuation, it may be needed to stop ACEI or ARB (e.g. hypotension with beginning sepsis) irrespective of the study.

Eligibility Criteria

Inclusion Criteria:

- Female and male patients competent to make a decision

- Proven and symptomatic SARS-CoV2 infection ≤ 5 days

- Patient age ≥ 18 years

- Provided written informed consent

- Chronic (≥ 1 month) ACEI/ARB therapy for treatment of arterial hypertension, diabetes
mellitus, heart failure or coronary artery disease

- Stable hemodynamic conditions allowing to stop or continue treatment with ACEI/ARB
(systolic blood pressure ≤180mmHg)

Exclusion Criteria:

- Women capable of bearing children as well as pregnant and breastfeeding women

- Participant in another interventional trail

- At screening visit, no oral medication intake possible

- Advanced heart failure NYHA Stage III-IV

- Left ventricular ejection fraction <30% or NTproBNP ≥600pg/mL in case of clinical
signs of heart failure

- Acute coronary syndrome ≤ 3 months

- Severe arterial hypertension (concomitant use of more than 4 different
antihypertensive drug classes)

- Acute respiratory distress syndrome with need for mechanical ventilation

- Patients who at not capable of home blood pressure monitoring

- Patients who cannot be switched to an alternative medication

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Austria
Germany
Locations

Medical University Innsbruck, University Hospital of Internal Medicine III
Innsbruck, Tyrol, Austria

Medical University of Graz
Graz, Austria

Landeskrankenhaus Hall
Hall In Tirol, Austria

Medical University Innsbruck, Intensive Care and Emergency Medicine Department
Innsbruck, Austria

Medical University Innsbruck, University Hospital of Internal Medicine II
Innsbruck, Austria

Medical University Innsbruck, University Hospital of Internal Medicine IV
Innsbruck, Austria

Medical University Innsbruck, University Hospital of Internal Medicine I
Innsbruck, Austria

Medical University Innsbruck, University Hospital of Internal Medicine V
Innsbruck, Austria

Klinikum Klagenfurt
Klagenfurt, Austria

Bezirkskrankenhaus Kufstein
Kufstein, Austria

Klinikum Lienz
Lienz, Austria

Bezirkskrankenhaus St. Johann
Sankt Johann In Tirol, Austria

Bezirkskrankenhaus Schwaz
Schwaz, Austria

Krankenhaus St. Vinzenz Zams
Zams, Austria

LMU Klinikum, Medizinische Klinik I
Munich, Bavaria, Germany

University Hospital Aachen
Aachen, Germany

University Hospital Augsburg
Augsburg, Germany

Asklepios Stadtklinik Bad Tölz
Bad Tölz, Germany

Klinikum Dachau
Dachau, Germany

University Hospital Erlangen
Erlangen, Germany

University Hospital Essen
Essen, Germany

University of Freiburg
Freiburg, Germany

Klinikum Memmingen
Memmingen, Germany

LMU Klinikum, Medizinische Klinik III
Munich, Germany

LMU Klinikum, Medizinische Klinik II
Munich, Germany

LMU Klinikum, Medizinische Klinik IV
Munich, Germany

München Klinik Bogenhausen und Schwabing
Munich, Germany

Rotkreuzklinikum Munich
Munich, Germany

Krankenhaus Mühldorf
Mühldorf, Germany

Klinikum Rosenheim
Rosenheim, Germany

Krankenhaus Weiden
Weiden, Germany

Medical University Innsbruck
NCT Number
Keywords
ACE-inhibitors
RAS system
angiotensin receptor blockers
SARS-CoV-2
Covid-19
MeSH Terms
COVID-19
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists