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NCT Number: NCT04353596

Stopping ACE-inhibitors in COVID-19

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Innsbruck, University Hospital of Internal Medicine III, Innsbruck, Tyrol, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Composite of the Maximum Sequential Organ Failure Assessment (SOFA) Score and Death Within 30 Days

    Time frame: 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).

  2. Composite of Admission to an Intensive Care Unit (ICU), the Use of Mechanical Ventilation, or All-cause Death

    Time frame: 30 days

    Composite of admission to ICU, mechanical ventilation, and death

Secondary outcomes

  1. Mean 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)

  2. Rates of Non-invasive Ventilation

    Time frame: 30 days

    Number of Participants with Non-invasive Ventilation

  3. Rates of Renal Replacement Therapies

    Time frame: 30 days

  4. Number of Patients With Systolic/Diastolic Blood Pressure > 180/120 mmHg

    Time frame: 30 days

  5. Hospitalisation Due to Cardiac Decompensation

    Time frame: 30 days

    with causal relationship to stopping of ACEI/ARB therapy

  6. Rates of Mechanical Ventilation

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

Stopping ACE-inhibitors in COVID-19: A Randomized Controlled Trial

Acronym: ACEI-COVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2020
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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