Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stopping/replacing ACEI/ARB | Experimental | Chronic treatment with ACEI or ARB will be stopped or replaced. |
|
| Control | No Intervention | No intervention, which means further treatment with ACEI or ARB. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE inhibitor, angiotensin receptor blocker | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of Sequential Organ Failure Assessment (SOFA) Score | minimum score is 0, maximum score is 24; higher score indicates poor outcome (death-adjusted) | 30 days |
| Rates of Non-invasive Ventilation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck, University Hospital of Internal Medicine III | Innsbruck | Tyrol | 6020 | Austria | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34126053 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Of 2301 patients, who were assessed for eligibility, 216 underwent randomization. 1921 were excluded due violation of inclusion or exclusion criteria.
Between April 20, 2020, and Jan 20, 2021, 204 participants were randomly assigned to discontinuation (n=109) or continuation (n=107) of RAS inhibition, at 35 centres, including 19 university clinics and 16 large referral hospitals, in Austria and Germany.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Discontinuation Group | Discontinuation of chronic ACEI or ARB pretreatment |
| FG001 | Continuation Group | Continuation of chronic ACEI or ARB pretreatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2020 |
Not provided
Not provided
open-label, randomized design
Not provided
Not provided
unmasked
|
Number of Participants with 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 | with causal relationship to stopping of ACEI/ARB therapy | 30 days |
| Rates of Mechanical Ventilation | 30 days |
| 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 |
| Per Protocol |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Discontinuation Group | Chronic pretreatment with ACEI or ARB will be stopped or replaced. Substitution with an alternative substance class was at the discretion of the treating physician |
| BG001 | Continuation Group | No intervention, which means further treatment with ACEI or ARB. In patients, randomized to continuation, it may be needed to stop ACEI or ARB (e.g. hypotension with beginning sepsis) irrespective of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Median | Inter-Quartile Range | "kg per m^2" |
| |||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Current Smoker | Count of Participants | Participants |
| ||||||||||||||||
| Dyslipidaemia | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Coronary artery disease | Count of Participants | Participants |
| ||||||||||||||||
| Heart failure | Count of Participants | Participants |
| ||||||||||||||||
| Chronic obstructive pulmonary disease | Count of Participants | Participants |
| ||||||||||||||||
| Atrial fibrillation | Count of Participants | Participants |
| ||||||||||||||||
| Malignant disease | Count of Participants | Participants |
| ||||||||||||||||
| Kidney disease | Count of Participants | Participants |
| ||||||||||||||||
| History of stroke | Count of Participants | Participants |
| ||||||||||||||||
| Angiotensin-converting enzyme inhibitor | Count of Participants | Participants |
| ||||||||||||||||
| Angiotensin II receptor blocker | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 30 days |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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 | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean of Sequential Organ Failure Assessment (SOFA) Score | minimum score is 0, maximum score is 24; higher score indicates poor outcome (death-adjusted) | Posted | Mean | Inter-Quartile Range | score on a scale | 30 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Rates of Non-invasive Ventilation | Number of Participants with Non-invasive Ventilation | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Rates of Renal Replacement Therapies | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Systolic/Diastolic Blood Pressure > 180/120 mmHg | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Hospitalisation Due to Cardiac Decompensation | with causal relationship to stopping of ACEI/ARB therapy | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Rates of Mechanical Ventilation | Posted | Count of Participants | Participants | 30 days |
|
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Discontinuation Group | Discontinuation of ACEI or ARB therapy | 8 | 104 | 25 | 104 | 13 | 104 |
| EG001 | Continuation Group | Continuation of ACEI or ARB therapy | 12 | 100 | 28 | 100 | 7 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of respiratory function | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Ischemic events | Cardiac disorders | Systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Worsening of general condition | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of respiratory function | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Elevation of creatinine | Renal and urinary disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Worsening of general condition | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Axel Bauer | Medizinische Universität Innsbruck/ Medical University Innsbruck | 0043 512 504 25621 | Axel.Bauer@i-med.ac.at |
| May 3, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D057911 | Angiotensin Receptor Antagonists |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Germany |
|
|
|
|
|
|
|
|