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SARS-CoV-2Phase 4ACEI-COVIDNCT04353596

Stopping ACE-inhibitors in COVID-19

A Phase 4 study testing ACE inhibitor, angiotensin receptor blocker in people with SARS-CoV-2 and COVID-19, run by Medical University Innsbruck at 31 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV-2, COVID-19
What is being tested?
ACE inhibitor, angiotensin receptor blocker
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
31 sitesin 2 countries
Study dates
20 Apr 2020to 24 Feb 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

Germany17 sites

  • University Hospital Aachen

    Aachen

  • University Hospital Augsburg

    Augsburg

  • Asklepios Stadtklinik Bad Tölz

    Bad Tölz

  • Klinikum Dachau

    Dachau

  • University Hospital Erlangen

    Erlangen

  • University Hospital Essen

    Essen

  • University of Freiburg

    Freiburg im Breisgau

  • Klinikum Memmingen

    Memmingen

  • Krankenhaus Mühldorf

    Mühldorf

  • LMU Klinikum, Medizinische Klinik I

    Munich, Bavaria, 81377

  • LMU Klinikum, Medizinische Klinik III

    Munich

  • LMU Klinikum, Medizinische Klinik II

    Munich

  • LMU Klinikum, Medizinische Klinik IV

    Munich

  • München Klinik Bogenhausen und Schwabing

    Munich

  • Rotkreuzklinikum Munich

    Munich

  • Klinikum Rosenheim

    Rosenheim

  • Krankenhaus Weiden

    Weiden

Other trials in Germany

Austria14 sites

  • Medical University of Graz

    Graz

  • Landeskrankenhaus Hall

    Hall in Tirol

  • Medical University Innsbruck, University Hospital of Internal Medicine III

    Innsbruck, Tyrol, 6020

  • Medical University Innsbruck, Intensive Care and Emergency Medicine Department

    Innsbruck

  • Medical University Innsbruck, University Hospital of Internal Medicine II

    Innsbruck

  • Medical University Innsbruck, University Hospital of Internal Medicine IV

    Innsbruck

  • Medical University Innsbruck, University Hospital of Internal Medicine I

    Innsbruck

  • Medical University Innsbruck, University Hospital of Internal Medicine V

    Innsbruck

  • Klinikum Klagenfurt

    Klagenfurt

  • Bezirkskrankenhaus Kufstein

    Kufstein

  • Klinikum Lienz

    Lienz

  • Bezirkskrankenhaus St. Johann

    Sankt Johann in Tirol

  • Bezirkskrankenhaus Schwaz

    Schwaz

  • Krankenhaus St. Vinzenz Zams

    Zams

Other trials in Austria

About this study

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

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

Read the detailed 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.

Conditions
SARS-CoV-2, COVID-19
Being tested
ACE inhibitor, angiotensin receptor blocker
Keywords
ACE-inhibitors, RAS system, angiotensin receptor blockers, SARS-CoV-2, COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACE inhibitor, angiotensin receptor blockerDrug

    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.

Study groups in NCT04353596
Study groupRoleWhat they receive
Stopping/replacing ACEI/ARBExperimentalChronic treatment with ACEI or ARB will be stopped or replaced.
Receives: Drug: ACE inhibitor, angiotensin receptor blocker
ControlNo interventionNo intervention, which means further treatment with ACEI or ARB.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 days

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

    Composite of admission to ICU, mechanical ventilation, and death

    Measured: 30 days

Secondary outcomes (6)

  1. Mean of Sequential Organ Failure Assessment (SOFA) Score

    minimum score is 0, maximum score is 24; higher score indicates poor outcome (death-adjusted)

    Measured: 30 days

  2. Rates of Non-invasive Ventilation

    Number of Participants with Non-invasive Ventilation

    Measured: 30 days

  3. Rates of Renal Replacement Therapies

    Measured: 30 days

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

    Measured: 30 days

  5. Hospitalisation Due to Cardiac Decompensation

    with causal relationship to stopping of ACEI/ARB therapy

    Measured: 30 days

  6. Rates of Mechanical Ventilation

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2020
  2. Study start20 Apr 2020
  3. Primary completion16 Feb 2021
  4. Study completion24 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
open-label, randomized design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353596
Sponsor's protocol ID
EudraCT 2020-001206-35
Acronym
ACEI-COVID
Status last verified
Feb 2021
First submitted
14 Apr 2020
Last updated
13 Sep 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bauer A, Schreinlechner M, Sappler N, Dolejsi T, Tilg H, Aulinger BA, Weiss G, Bellmann-Weiler R, Adolf C, Wolf D, Pirklbauer M, Graziadei I, Ganzer H, von Bary C, May AE, Woll E, von Scheidt W, Rassaf T, Duerschmied D, Brenner C, Kaab S, Metzler B, Joannidis M, Kain HU, Kaiser N, Schwinger R, Witzenbichler B, Alber H, Straube F, Hartmann N, Achenbach S, von Bergwelt-Baildon M, von Stulpnagel L, Schoenherr S, Forer L, Embacher-Aichhorn S, Mansmann U, Rizas KD, Massberg S; ACEI-COVID investigators. Discontinuation versus continuation of renin-angiotensin-system inhibitors in COVID-19 (ACEI-COVID): a prospective, parallel group, randomised, controlled, open-label trial. Lancet Respir Med. 2021 Aug;9(8):863-872. doi: 10.1016/S2213-2600(21)00214-9. Epub 2021 Jun 11.

    PubMed 34126053

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ACE inhibitor, angiotensin receptor blocker in people with SARS-CoV-2 and COVID-19, run by Medical University Innsbruck at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of the Maximum Sequential Organ Failure Assessment (SOFA) Score and Death Within 30 Days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353596, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.

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