Stopping ACE-inhibitors in COVID-19
ACEI-COVID
1 other identifier
interventional
216
2 countries
31
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2020
Shorter than P25 for phase_4
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedStudy Start
First participant enrolled
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2021
CompletedResults Posted
Study results publicly available
September 13, 2022
CompletedSeptember 13, 2022
February 1, 2021
10 months
April 14, 2020
May 5, 2022
August 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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
30 days
Secondary Outcomes (6)
Mean of Sequential Organ Failure Assessment (SOFA) Score
30 days
Rates of Non-invasive Ventilation
30 days
Rates of Renal Replacement Therapies
30 days
Number of Patients With Systolic/Diastolic Blood Pressure > 180/120 mmHg
30 days
Hospitalisation Due to Cardiac Decompensation
30 days
- +1 more secondary outcomes
Study Arms (2)
Stopping/replacing ACEI/ARB
EXPERIMENTALChronic treatment with ACEI or ARB will be stopped or replaced.
Control
NO INTERVENTIONNo intervention, which means further treatment with ACEI or ARB.
Interventions
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
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Medical University Innsbruck, University Hospital of Internal Medicine III
Innsbruck, Tyrol, 6020, 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, 81377, 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 im Breisgau, 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
Related Publications (1)
Bauer A, Schreinlechner M, Sappler N, Dolejsi T, Tilg H, Aulinger BA, Weiss G, Bellmann-Weiler R, Adolf C, Wolf D, Pirklbauer M, Graziadei I, Ganzer H, von Bary C, May AE, Woll E, von Scheidt W, Rassaf T, Duerschmied D, Brenner C, Kaab S, Metzler B, Joannidis M, Kain HU, Kaiser N, Schwinger R, Witzenbichler B, Alber H, Straube F, Hartmann N, Achenbach S, von Bergwelt-Baildon M, von Stulpnagel L, Schoenherr S, Forer L, Embacher-Aichhorn S, Mansmann U, Rizas KD, Massberg S; ACEI-COVID investigators. Discontinuation versus continuation of renin-angiotensin-system inhibitors in COVID-19 (ACEI-COVID): a prospective, parallel group, randomised, controlled, open-label trial. Lancet Respir Med. 2021 Aug;9(8):863-872. doi: 10.1016/S2213-2600(21)00214-9. Epub 2021 Jun 11.
PMID: 34126053DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Dr. Axel Bauer
- Organization
- Medizinische Universität Innsbruck/ Medical University Innsbruck
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- unmasked
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2020
First Posted
April 20, 2020
Study Start
April 20, 2020
Primary Completion
February 16, 2021
Study Completion
February 24, 2021
Last Updated
September 13, 2022
Results First Posted
September 13, 2022
Record last verified: 2021-02