Stopping ACE-inhibitors in COVID-19 (ACEI-COVID)

Medical University Innsbruck

Status and phase

Completed

Phase 4

Conditions

COVID-19

SARS-CoV-2

Treatments

Drug: ACE inhibitor, angiotensin receptor blocker

Study type

Interventional

Funder types

Other

Identifiers

NCT04353596

EudraCT 2020-001206-35

Details and patient eligibility

About

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

Full description

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.

Enrollment

216 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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