Stopping ACE-inhibitors in COVID-19
- Conditions
- SARS-CoV-2COVID-19
- Interventions
- Drug: ACE inhibitor, angiotensin receptor blocker
- Registration Number
- NCT04353596
- Lead Sponsor
- Medical University Innsbruck
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stopping/replacing ACEI/ARB ACE inhibitor, angiotensin receptor blocker Chronic treatment with ACEI or ARB will be stopped or replaced.
- Primary Outcome Measures
Name Time Method Composite of the Maximum Sequential Organ Failure Assessment (SOFA) Score and Death Within 30 Days 30 days The score is calculated from six different components, each of which reflects the status of an organ system, including respiratory function, cardiovascular integrity, liver function, coagulation, renal function and neurological status. The score can range from 0 (best) to 24 (worst). In case of death, the patient was by definition assigned the maximum value of 24. Outpatients were assigned a value of 0 or 24 (in the case of death).
Composite of Admission to an Intensive Care Unit (ICU), the Use of Mechanical Ventilation, or All-cause Death 30 days Composite of admission to ICU, mechanical ventilation, and death
- Secondary Outcome Measures
Name Time Method Rates of Non-invasive Ventilation 30 days Number of Participants with Non-invasive Ventilation
Number of Patients With Systolic/Diastolic Blood Pressure > 180/120 mmHg 30 days Rates of Mechanical Ventilation 30 days Rates of Renal Replacement Therapies 30 days Mean of Sequential Organ Failure Assessment (SOFA) Score 30 days minimum score is 0, maximum score is 24; higher score indicates poor outcome (death-adjusted)
Hospitalisation Due to Cardiac Decompensation 30 days with causal relationship to stopping of ACEI/ARB therapy
Trial Locations
- Locations (31)
Landeskrankenhaus Hall
🇦🇹Hall In Tirol, Austria
Bezirkskrankenhaus Kufstein
🇦🇹Kufstein, Austria
Medical University of Graz
🇦🇹Graz, Austria
Bezirkskrankenhaus Schwaz
🇦🇹Schwaz, Austria
Klinikum Dachau
🇩🇪Dachau, Germany
University Hospital Erlangen
🇩🇪Erlangen, Germany
Rotkreuzklinikum Munich
🇩🇪Munich, Germany
LMU Klinikum, Medizinische Klinik III
🇩🇪Munich, Germany
Medical University Innsbruck, University Hospital of Internal Medicine III
🇦🇹Innsbruck, Tyrol, 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
Klinikum Klagenfurt
🇦🇹Klagenfurt, Austria
Krankenhaus St. Vinzenz Zams
🇦🇹Zams, Austria
Bezirkskrankenhaus St. Johann
🇦🇹Sankt Johann In Tirol, Austria
University Hospital Aachen
🇩🇪Aachen, Germany
University Hospital Augsburg
🇩🇪Augsburg, Germany
LMU Klinikum, Medizinische Klinik I
🇩🇪Munich, Bavaria, Germany
University Hospital Essen
🇩🇪Essen, Germany
University of Freiburg
🇩🇪Freiburg, Germany
Asklepios Stadtklinik Bad Tölz
🇩🇪Bad Tölz, Germany
LMU Klinikum, Medizinische Klinik II
🇩🇪Munich, Germany
München Klinik Bogenhausen und Schwabing
🇩🇪Munich, Germany
Krankenhaus Mühldorf
🇩🇪Mühldorf, Germany
LMU Klinikum, Medizinische Klinik IV
🇩🇪Munich, Germany
Klinikum Rosenheim
🇩🇪Rosenheim, Germany
Krankenhaus Weiden
🇩🇪Weiden, Germany
Klinikum Memmingen
🇩🇪Memmingen, Germany
Medical University Innsbruck, Intensive Care and Emergency Medicine Department
🇦🇹Innsbruck, Austria
Medical University Innsbruck, University Hospital of Internal Medicine V
🇦🇹Innsbruck, Austria
Klinikum Lienz
🇦🇹Lienz, Austria