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Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 (APN01-COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335136
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Apeiron Biologics

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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: RhACE2 APN01 Drug: Physiological saline solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Active Comparator: 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 Names:
  • APN01
  • Recombinant human angiotensin-converting enzyme 2

Placebo Comparator: Group B (placebo control) Drug: Physiological saline solution
Patients will be treated with placebo intravenously twice daily (BID).




Primary Outcome Measures :
  1. Cause of death or invasive mechanical ventilation [ Time Frame: 28 days ]
    The primary endpoint is a composite endpoint of all cause-death or invasive mechanical ventilation up to 28 days or hospital discharge


Secondary Outcome Measures :
  1. LDH level [ Time Frame: Day 5 ]
    Log transformed levels of Lactate dehydrogenase (LDH) at day 5 as a surrogate marker for organ damage (powered secondary endpoint

  2. Mortality [ Time Frame: 28 days ]
    28-day mortality (all cause-death)

  3. VFD [ Time Frame: 28 days ]
    Ventilator-free days (VFD) up to 28 days or hospital discharge

  4. Time to death [ Time Frame: 28 days ]
    Time to death (all causes)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Any patient whose clinical condition is deteriorating rapidly
  2. Known 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 trials for COVID-19 within 30 days before ICF
  9. Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335136


Contacts
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Contact: Sonja Höller, Dr. 43 1 865 65 77 128 sonja.hoeller@apeiron-biologics.com
Contact: Claudia Haider, Mag. 43 1 8656577 110 claudia.haider@apeiron-biologics.com

Locations
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Austria
Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria
Contact: Günter Weiss, Univ.-Prof. Dr.         
Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin Recruiting
Wien, Austria
Contact: Alexander Zoufaly, Priv.-Doz. Dr.         
Medizinische Universität Wien Recruiting
Wien, Austria
Contact: Roman Ullrich, Prof. Dr.         
Denmark
The National University Hospital, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Jan Gerstoft, Prof. Dr. med.         
Herlev Gentofte Hospital Recruiting
Herlev, Denmark, 2730
Contact: Christian Søborg         
Nordsjællands Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Troels B. Knudsen         
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Thomas L. Benfield, Prof.         
Germany
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany
Contact: Stefan Schmiedel, Dr. med.         
Klinikum rechts der Isar, Technische Universität München Recruiting
München, Germany
Contact: Christoph D. Spinner, PD DR. med.         
Sponsors and Collaborators
Apeiron Biologics
Investigators
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Principal Investigator: 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
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Responsible Party: Apeiron Biologics
ClinicalTrials.gov Identifier: NCT04335136    
Other Study ID Numbers: APN01-01-COVID19
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No