Stopping ACE-inhibitors in COVID-19 (ACEI-COVID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04353596|
Recruitment Status : Completed
First Posted : April 20, 2020
Last Update Posted : March 2, 2021
|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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||open-label, randomized design|
|Masking:||Single (Outcomes Assessor)|
|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|
Experimental: Stopping/replacing ACEI/ARB
Chronic treatment with ACEI or ARB will be stopped or replaced.
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.
No Intervention: Control
No intervention, which means further treatment with ACEI or ARB.
- 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
- 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 ]
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