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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 : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Apeiron Biologics

Study Description
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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

Study Design
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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 : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. All Cause-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)


Eligibility Criteria
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Ages Eligible for Study:   18 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 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)
Contacts and Locations
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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

Locations
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Sponsors and Collaborators
Apeiron Biologics
Investigators
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Principal Investigator: Henning Bundgaard, MD. Cap. Region's Unit of Inherited Cardiac Diseases, Faculty Health&Medical
More Information
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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: October 6, 2020
Last Verified: May 2020

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