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History of Changes for Study: NCT04335136
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 (APN01-COVID-19)
Latest version (submitted July 29, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 3, 2020 None (earliest Version on record)
2 May 4, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 June 15, 2020 Eligibility, Contacts/Locations and Study Status
4 July 16, 2020 Outcome Measures and Study Status
5 September 24, 2020 Contacts/Locations, Study Status and Oversight
6 October 5, 2020 Contacts/Locations and Study Status
7 January 21, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 June 7, 2021
Quality Control Review has not concluded Returned: June 11, 2021
Outcome Measures, Study Status, Document Section and Study Design
9 July 16, 2021
Quality Control Review has not concluded Returned: July 16, 2021
Outcome Measures, Participant Flow, Study Status, Baseline Characteristics and Study Design
10 July 29, 2021 Study Status, Outcome Measures
Comparison Format:

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Study NCT04335136
Submitted Date:  April 3, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: APN01-01-COVID19
Brief Title: Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 (APN01-COVID-19)
Official Title: Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: April 2020
Primary Completion: September 2020 [Anticipated]
Study Completion: November 2020 [Anticipated]
First Submitted: April 1, 2020
First Submitted that
Met QC Criteria:
April 3, 2020
First Posted: April 6, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 3, 2020
Last Update Posted: April 6, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Apeiron Biologics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: COVID-19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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).
Open or close this module Outcome Measures
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)
Open or close this module Eligibility
Minimum Age: 35 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Central Contact Person: Sonja Höller, Dr.
Telephone: 43 1 865 65 77 128
Email: sonja.hoeller@apeiron-biologics.com
Central Contact Backup: Claudia Haider, Mag.
Telephone: 43 1 8656577 110
Email: claudia.haider@apeiron-biologics.com
Study Officials: Henning Bundgaard, Prof. Dr. med.
Principal Investigator
The Capital Region's Unit of Inherited Cardiac Diseases Faculty of Health and Medical Sciences University of Copenhagen Rigshospitalet, University of Copenhagen
Locations: Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Contact:Contact: Günter Weiss, Univ.-Prof. Dr.
Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin
Wien, Austria
Contact:Contact: Alexander Zoufaly, Priv.-Doz. Dr.
Medizinische Universität Wien
Wien, Austria
Contact:Contact: Roman Ullrich, Prof. Dr.
Denmark
The National University Hospital, Rigshospitalet
Copenhagen, Denmark
Contact:Contact: Jan Gerstoft, Prof. Dr. med.
Herlev Gentofte Hospital
Herlev, Denmark, 2730
Contact:Contact: Christian Søborg
Nordsjællands Hospital
Hillerød, Denmark, 3400
Contact:Contact: Troels B. Knudsen
Hvidovre Hospital
Hvidovre, Denmark, 2650
Contact:Contact: Thomas L. Benfield, Prof.
Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Contact:Contact: Stefan Schmiedel, Dr. med.
Klinikum rechts der Isar, Technische Universität München
München, Germany
Contact:Contact: Christoph D. Spinner, PD DR. med.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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