Phase 4
N=216
Stopping ACE-inhibitors in COVID-19
SARS-CoV-2 · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04353596 ↗Enrolled (actual)
216
Serious AEs
26.0%
Results posted
Sep 2022
Primary outcome: Primary: Composite of the Maximum Sequential Organ Failure Assessment (SOFA) Score and Death Within 30 Days — 0; 1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ACE inhibitor, angiotensin receptor blocker (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University Innsbruck
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of the Maximum Sequential Organ Failure Assessment (SOFA) Score and Death Within 30 Days |
0; 1 | — |
| PRIMARY Composite of Admission to an Intensive Care Unit (ICU), the Use of Mechanical Ventilation, or All-cause Death |
21; 26 | — |
| SECONDARY Mean of Sequential Organ Failure Assessment (SOFA) Score |
0; 0.12 | — |
| SECONDARY Rates of Non-invasive Ventilation |
19; 14 | — |
| SECONDARY Rates of Renal Replacement Therapies |
0; 1 | — |
| SECONDARY Number of Patients With Systolic/Diastolic Blood Pressure > 180/120 mmHg |
7; 7 | — |
| SECONDARY Hospitalisation Due to Cardiac Decompensation |
0; 0 | — |
| SECONDARY Rates of Mechanical Ventilation |
10; 8 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04353596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.