Official Title
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.

Completed
COVID-19

Drug: RhACE2 APN01

Patients will be treated with APN01 intravenously twice daily (BID).
Other Name: Array

Drug: Physiological saline solution

Patients will be treated with placebo intravenously twice daily (BID).

Eligibility 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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Austria
Denmark
Germany
Russian Federation
United Kingdom
Locations

Medizinische Universität Innsbruck
Innsbruck, Austria

Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin
Wien, Austria

Medizinische Universität Wien
Wien, Austria

The National University Hospital, Rigshospitalet
Copenhagen, Denmark

Herlev Gentofte Hospital
Herlev, Denmark

Nordsjællands Hospital
Hillerød, Denmark

Hvidovre Hospital
Hvidovre, Denmark

Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany

Klinikum rechts der Isar, Technische Universität München
München, Germany

Regional State Budgetary Educational Institution "Clinical Hospital № 5, Barnaul"
Barnaul, Russian Federation

State Healthcare Institution "State Clinical Hspital № 15 named after O.M. Filatov"
Moscow, Russian Federation

Moscow State Budgetary Healthcare Institution "City Clinical Hospital №52 of Health Department of Moscow"
Moscow, Russian Federation

Moscow State Budgetary Healthcare Institution "N.V. Sklifosovsky Research Institute for Emergency Medicine of Health Department of Moscow"
Moscow, Russian Federation

Saint Petersburg SBHI City Hospital 38 named after N A Semashko
Pushkin, Russian Federation

Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after I.P. Pavlov" HD RF
Ryazan, Russian Federation

Alexandrovskaya Hospital
Saint-Petersburg, Russian Federation

Saint-Petersburg State Budget Healthcare Institution City Hospital 15
Saint-Petersburg, Russian Federation

Federal State Budgetary Educational Institution of Higher Education " Saratov State Medical University named after V.I. Razumovsky" HD RF
Saratov, Russian Federation

Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
Smolensk, Russian Federation

State budgetary institution of Healthcare of Tver region "Regional clinical hospital"
Tver, Russian Federation

Yaroslavl Regional Clinical Hospital for Military Veterans - International Centre for Gerontological Problems "Healthy Ageing"
Yaroslavl, Russian Federation

Cambridge University Hospitals NHS Trust/University of Cambridge
Cambridge, United Kingdom

Henning Bundgaard, MD., Principal Investigator
Cap. Region's Unit of Inherited Cardiac Diseases, Faculty Health&Medical

Apeiron Biologics
NCT Number
MeSH Terms
COVID-19