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