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Recombinant human angiotensin-converting enzyme 2 (rhACE2) as a treat-ment for patients with COVID-19

Trial Profile

Recombinant human angiotensin-converting enzyme 2 (rhACE2) as a treat-ment for patients with COVID-19

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2020

At a glance

  • Drugs GSK 2586881 (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms APN01-COVID-19
  • Sponsors Apeiron Biologics
  • Most Recent Events

    • 05 Jun 2020 According to an Apeiron Biologics media release, the company plans to expand the trial to USA and Russia.
    • 04 May 2020 Status changed from not yet recruiting to recruiting.
    • 03 Apr 2020 New trial record

Trial Overview

Purpose

Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with COVID-19 to block viral entry and decrease viral replication.

Primary Endpoints

Cause of death or invasive mechanical ventilation

description: The primary endpoint is a composite endpoint of all cause-death or invasive mechanical ventilation up to 28 days or hospital discharge
time_frame: 28 days

Other Endpoints

1. Log transformed levels of Lactate dehydrogenase (LDH) at day 5 as a surrogate marker for organ damage (powered secondary endpoint) 2. 28-day mortality (all cause-death) 3. Ventilator-free days (VFD) up to 28 days or hospital discharge 4. Proportion of responders, defined as ≥2 improvement in WHO's 11-Point Score system at day 7, 10, 14 and 28 5. Time to death (all cause) 6. Proportion of patients with any use of invasive mechanical ven-tilation up to 28 days or hospital discharge 7. Time to first use of invasive mechanical ventilation up to 28 days or hospital discharge 8. Absolute values and absolute change in P/F ratio over time 9. Absolute values and absolute change in the modified Sequential organ failure assessment score (mSOFA score) over time 10. Time to a 2-point decrease in WHO scoring scheme 11. Absolute values and absolute change in lymphocyte counts over time 12. Absolute values and absolute change in C-reactive protein levels over time 13. Absolute values and absolute change in D-dimer over time 14. Absolute values and absolute change in log transformed levels of LDH over time 15. Time to hospital discharge 16. Change in viral RNA over time Biomarker endpoints: Absolute values and absolute changes in relevant biomarkers over time: 1. Angiotensin II (Ang II), Angiotensin 1-7 (Ang 1-7), Angiotensin 1-5 (Ang 1-5), renin and aldosterone, Angiotensin-converting enzyme (ACE), Angiotensin-converting enzyme 2 (ACE2), Angiotensin I (Ang I), Angiotensin 1-9 (Ang 1-9) 2. Cytokines: Interleukin 6 (IL-6), Interleukin 8 (IL-8), soluble Tumor Necrosis Factor receptor type II (sTNFrII), Plasminogen Activator Inhibitor type-1 (PAI-1), von Willebrand Factor (vWF), Tumor necrosis factor-α (TNF-α) 3. Alveolar epithelial markers: soluble Receptor for Advanced Glycation End products (sRAGE), Surfactant protein-D(SP-D) 4. Endothelial markers: Angiopoietin-2 5. Change in clinical laboratory markers associated with poor outcome over time (e.g., lymphocyte counts, hsTnI (high sensitivity troponin)) 6. NT-proBNP Safety endpoints: Frequency of adverse events (AEs) and serious adverse events (SAEs) in vital signs, clinical laboratory assessments and in ECG parameters Timepoint: Continioulsy over the duration of the trial [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 200

  • Sex male & female
  • Age Group 18-80 years; adult; elderly

Patient Inclusion Criteria

1. Hospitalized male or female 2. Diagnosed to be COVID-19 POSITIV 3. Signed Inform Consent Form

Patient Exclusion Criteria

1. Any patient whose clinical condition is deteriorating rapidly 2. Known history of positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody 3. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation 4. Pregnant females as determined by positive serum or urine hCG test prior to dosing 5. Lung transplantation 6. Pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis or peritoneal dialysis 7. There are other uncontrolled co-morbidities that increase the risks associated with the study drug administration, that are assessed by the medical expert team as unsuitable 8. Patient in clinical trials for COVID-19 within 30 days before ICF 9. Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants)

Trial Details

Identifiers

Identifier Owner
NCT04335136 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001172-15 European Clinical Trials Database
APN01-01COVID19 -

Organisations

  • Sponsors Apeiron Biologics
  • Affiliations Apeiron Biologics

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

    Actual : 30 Apr 2020

  • Primary Completion Dates

    Planned : 01 Sep 2020

  • End Dates

    Planned : 01 Nov 2020

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location Austria; Denmark; Germany; Russia; United Kingdom; USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
GSK 2586881Primary Drug Intravenous Infusion

Group A (active) APN01

Recombinant human angiotensin-converting enzyme 2 (rhACE2) - APN01
Drug: RhACE2 APN01 (Patients will be treated with APN01 intravenously twice daily (BID).) Other Name: APN01, Recombinant human angiotensin-converting enzyme 2

Group B (placebo control)

Drug: Physiological saline solution (Patients will be treated with placebo intravenously twice daily (BID).)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Alexander Zoufaly, Priv.-Doz. Dr. Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin Austria
Christian Søborg Herlev Gentofte Hospital Denmark
Christoph D. Spinner, PD DR. med. Klinikum rechts der Isar, Technische Universität München Germany
Claudia Haider, Mag.
43 1 8656577 110
claudia.haider@apeiron-biologics.com
show details
, Apeiron Biologics
-
Günter Weiss, Univ.-Prof. Dr. Medizinische Universität Innsbruck Austria
Henning Bundgaard, Prof. Dr. med. The Capital Region's Unit of Inherited Cardiac Diseases Faculty of Health and Medical Sciences University of Copenhagen Rigshospitalet, University of Copenhagen
-
Jan Gerstoft, Prof. Dr. med. The National University Hospital, Rigshospitalet Denmark
Roman Ullrich, Prof. Dr. Medizinische Universität Wien Austria
Sonja Höller, Dr.
43 1 865 65 77 128
sonja.hoeller@apeiron-biologics.com
show details
, Apeiron Biologics
-
SPONSOR
Campus-Vienna-Biocenter 5,
Vienna, 1030, Austria.
sonja.hoeller@apeiron-biologics.com
show details
APEIRON Biologics AG Austria
Stefan Schmiedel, Dr. med. Universitätsklinikum Hamburg-Eppendorf Germany
Thomas L. Benfield, Prof. Hvidovre Hospital Denmark
Troels B. Knudsen Nordsjællands Hospital Denmark

Centres

Centre Name Location Trial Centre Country
-
-
-
Apeiron Biologics
-
-
APEIRON Biologics AG Vienna Austria
Herlev Gentofte Hospital Herlev Denmark
Hvidovre Hospital Hvidovre Denmark
Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin Wien Austria
Klinikum rechts der Isar, Technische Universität München München Germany
Medizinische Universität Innsbruck Innsbruck Austria
Medizinische Universität Wien Wien Austria
Nordsjællands Hospital Hillerød Denmark
The Capital Region's Unit of Inherited Cardiac Diseases Faculty of Health and Medical Sciences University of Copenhagen Rigshospitalet, University of Copenhagen
-
-
The National University Hospital, Rigshospitalet Copenhagen Denmark
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany

Trial History

Event Date Event Type Comment
17 Sep 2020 Other trial event Last checked against the European Clinical Trials Database record Updated 17 Sep 2020
20 Jul 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 20 Jul 2020
05 Jun 2020 Other trial event According to an Apeiron Biologics media release, the company plans to expand the trial to USA and Russia. Updated 05 Jun 2020
04 May 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 06 May 2020
08 Apr 2020 Other trial event New source identified and integrated: (ClinicalTrials.gov: US National Institutes of Health: NCT04335136). Updated 08 Apr 2020
07 Apr 2020 Other trial event New source identified and integrated: (European Clinical Trials Database: EudraCT2020-001172-15). Updated 07 Apr 2020
03 Apr 2020 New trial record New trial record Updated 03 Apr 2020
02 Apr 2020 Other trial event According to an Apeiron Biologics media release, the University Medical Center Hamburg-Eppendorf and the Klinikum rechts der Isar of the Technical University of Munich; the Medical University of Vienna, the Kaiser Franz-Josef-Spital, Vienna, the Medical University of Innsbruck and the University Medical Center Salzburg; the National University Hospital, Rigshospitalet, the Herlev Gentofte Hospital, the Hvido Hospital, and the Nordsaellands Hospital will participate in this study. Updated 03 Apr 2020
02 Apr 2020 Other trial event According to an Apeiron Biologics media release, the Austrian Government has agreed to fund a significant portion of this trial. Prof. Henning Bundgaard is the principal investigator of this study. Updated 03 Apr 2020
02 Apr 2020 Other trial event According to an Apeiron Biologics media release, the company announced that it has received regulatory approvals in Austria, Germany and Denmark to initiate a Phase II clinical trial of APN01 to treat COVID-19 and the first patients are expected to be dosed shortly. Updated 03 Apr 2020

References

  1. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  3. Apeiron Biologics. APEIRON Biologics Initiates Phase II Clinical Trial of APN01 for Treatment of COVID-19. Media-Rel 2020;.

    Media Release
  4. Apeiron Biologics. APEIRON Biologics closes oversubscribed financing round of EUR 17.5 million for the development of APN01 against COVID-19. Media-Rel 2020;.

    Media Release
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