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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
216
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.
Composite of the Maximum Sequential Organ Failure Assessment (SOFA) Score and Death Within 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).
Time frame: 30 days
Composite of Admission to an Intensive Care Unit (ICU), the Use of Mechanical Ventilation, or All-cause Death
Composite of admission to ICU, mechanical ventilation, and death
Time frame: 30 days
Mean of Sequential Organ Failure Assessment (SOFA) Score
minimum score is 0, maximum score is 24; higher score indicates poor outcome (death-adjusted)
Time frame: 30 days
Rates of Non-invasive Ventilation
Number of Participants with Non-invasive Ventilation
Time frame: 30 days
Rates of Renal Replacement Therapies
Time frame: 30 days
Number of Patients With Systolic/Diastolic Blood Pressure > 180/120 mmHg
Time frame: 30 days
Hospitalisation Due to Cardiac Decompensation
with causal relationship to stopping of ACEI/ARB therapy
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 21 more locations
Rates of Mechanical Ventilation
Time frame: 30 days