Stopping ACE-inhibitors in COVID-19 (ACEI-COVID)
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| ClinicalTrials.gov Identifier: NCT04353596 |
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Recruitment Status :
Completed
First Posted : April 20, 2020
Last Update Posted : March 2, 2021
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Sponsor:
Medical University Innsbruck
Collaborators:
Ludwig-Maximilians - University of Munich
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Medical University Innsbruck
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| SARS-CoV-2 COVID-19 | Drug: ACE inhibitor, angiotensin receptor blocker | Phase 4 |
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 (Clinical Trial) |
| Actual Enrollment : | 216 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | open-label, randomized design |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | unmasked |
| Primary Purpose: | Treatment |
| Official Title: | Stopping ACE-inhibitors in COVID-19: A Randomized Controlled Trial |
| Actual Study Start Date : | April 20, 2020 |
| Actual Primary Completion Date : | February 16, 2021 |
| Actual Study Completion Date : | February 24, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Stopping/replacing ACEI/ARB
Chronic treatment with ACEI or ARB will be stopped or replaced.
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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. |
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No Intervention: Control
No intervention, which means further treatment with ACEI or ARB.
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Primary Outcome Measures :
- Combination of maximum Sequential Organ Failure Assessment (SOFA) Score and death [ Time Frame: 30 days ]The minimal value of the SOFA Score will be 0 and the maximal value 24 points. All-cause death is classified as the maximum score (24 points). In case of a subclinical disease progress without need for hospitalization, the SOFA score will be 0.
- Composite of admission to an intensive care unit (ICU), the use of mechanical ventilation, or all-cause death [ Time Frame: 30 days ]will be hierarchically tested after enrollment of 798 patients
Secondary Outcome Measures :
- Mean and area under the curve of Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: 30 days ]minimum score is 0, maximum score is 24; higher score indicates poor outcome (death-adjusted)
- Rates of non-invasive ventilation [ Time Frame: 30 days ]high-flow, continuous positive airway pressure therapy
- Rates of renal replacement therapies [ Time Frame: 30 days ]
- Change of viral burden [ Time Frame: 30 days ]
- Change of C-reactive protein (CRP), interleukin 6 (IL-6), D-Dimer, IL-6, hochsensitives Troponin (hsTN), NT-pro-brain natriuretic peptide (NT-pro BNP) [ Time Frame: 30 days ]
- Number of patients with systolic/diastolic blood pressure > 180/120 mmHg [ Time Frame: 30 days ]
- Hospitalisation due to cardiac decompensation [ Time Frame: 30 days ]with causal relationship to stopping of ACEI/ARB therapy
- Rates of mechanical ventilation [ Time Frame: 30 days ]
- Rates of clonal hematopoiesis of indeterminate potential (CHIP) [ Time Frame: 30 days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353596
Locations
Show 31 study locations
Sponsors and Collaborators
Medical University Innsbruck
Ludwig-Maximilians - University of Munich
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
| Responsible Party: | Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT04353596 |
| Other Study ID Numbers: |
EudraCT 2020-001206-35 |
| First Posted: | April 20, 2020 Key Record Dates |
| Last Update Posted: | March 2, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Medical University Innsbruck:
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ACE-inhibitors RAS system angiotensin receptor blockers SARS-CoV-2 COVID-19 |
Additional relevant MeSH terms:
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Angiotensin-Converting Enzyme Inhibitors Angiotensin Receptor Antagonists Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |