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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

Tracking Information
First Submitted Date  ICMJE April 1, 2020
First Posted Date  ICMJE April 6, 2020
Last Update Posted Date October 6, 2020
Actual Study Start Date  ICMJE April 30, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
  • 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
  • Mortality [ Time Frame: 28 days ]
    28-day mortality (all cause-death)
  • VFD [ Time Frame: 28 days ]
    Ventilator-free days (VFD) up to 28 days or hospital discharge
  • Time to death [ Time Frame: 28 days ]
    Time to death (all causes)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Official Title  ICMJE Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: RhACE2 APN01
    Patients will be treated with APN01 intravenously twice daily (BID).
    Other Names:
    • APN01
    • Recombinant human angiotensin-converting enzyme 2
  • Drug: Physiological saline solution
    Patients will be treated with placebo intravenously twice daily (BID).
Study Arms  ICMJE
  • Active Comparator: Group A (active) APN01
    Recombinant human angiotensin-converting enzyme 2 (rhACE2) - APN01
    Intervention: Drug: RhACE2 APN01
  • Placebo Comparator: Group B (placebo control)
    Intervention: Drug: Physiological saline solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sonja Höller, Dr. 43 1 865 65 77 128 sonja.hoeller@apeiron-biologics.com
Listed Location Countries  ICMJE Austria,   Denmark,   Germany,   Russian Federation,   United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04335136
Other Study ID Numbers  ICMJE APN01-01-COVID19
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Apeiron Biologics
Study Sponsor  ICMJE Apeiron Biologics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henning Bundgaard, MD. Cap. Region's Unit of Inherited Cardiac Diseases, Faculty Health&Medical
PRS Account Apeiron Biologics
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP