Clinical trial NCT04335136: Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Official title: Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Apeiron Biologics
Sponsor class: INDUSTRY
First posted: 2020-04-06
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: All Cause-death or Invasive Mechanical Ventilation
timeFrame: 28 days
Secondary outcomes:
measure: Lactate Dehydrogenase (LDH) Level
timeFrame: Day 5
measure: Mortality
timeFrame: 28 days
measure: Ventilator-free Days (VFD)
timeFrame: 28 days
measure: Time to Death
timeFrame: 28 days
measure: Number of Responders, Defined as ≥2 Improvement in World Health Organization (WHO)'s 11-Point Score System at Days 7, 10, 14 and 28
timeFrame: Day 7, Day 10, Day 14, Day 28
measure: Time to Hospital Discharge
timeFrame: Up to 28 days
measure: Viral Ribonucleic Acid (RNA).
timeFrame: Day 1, Day 3, Day 5, Day 7, Day 14, and Day 28/End of study (EOS)
measure: Time to a 2-point Decrease in WHO's 11-Point Score System
timeFrame: Up to 28 days.
measure: Number of Patients With Any Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge
timeFrame: Up to 28 days
measure: Time to First Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge
timeFrame: Up to 28 days
measure: PaO2/FiO2 Value
timeFrame: Day 1, Day 7, Day 10, Day 14, and Day 28
measure: Modified Sequential Organ Failure Assessment Score (mSOFA Score, Total Score)
timeFrame: Day -1 (Screening), Day 7, Day 10, Day 14, Day 28/End of study
measure: Lymphocyte Count
timeFrame: Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study
measure: C-reactive Protein Levels
timeFrame: Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study
measure: D-Dimer
timeFrame: Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study
measure: Log-transformed Levels of LDH
timeFrame: Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Wien
country: Austria
facility: Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Copenhagen
country: Denmark
facility: The National University Hospital, Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Gentofte Hospital
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: München
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München
city: Barnaul
country: Russian Federation
facility: Regional State Budgetary Educational Institution "Clinical Hospital № 5, Barnaul"
city: Moscow
country: Russian Federation
facility: State Healthcare Institution "State Clinical Hspital № 15 named after O.M. Filatov"
city: Moscow
country: Russian Federation
facility: Moscow State Budgetary Healthcare Institution "City Clinical Hospital №52 of Health Department of Moscow"
city: Moscow
country: Russian Federation
facility: Moscow State Budgetary Healthcare Institution "N.V. Sklifosovsky Research Institute for Emergency Medicine of Health Department of Moscow"
city: Pushkin
country: Russian Federation
facility: Saint Petersburg SBHI City Hospital 38 named after N A Semashko
city: Ryazan
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after I.P. Pavlov" HD RF
city: Saint-Petersburg
country: Russian Federation
facility: Alexandrovskaya Hospital
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budget Healthcare Institution City Hospital 15
city: Saratov
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education " Saratov State Medical University named after V.I. Razumovsky" HD RF
city: Smolensk
country: Russian Federation
facility: Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
city: Tver
country: Russian Federation
facility: State budgetary institution of Healthcare of Tver region "Regional clinical hospital"
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital for Military Veterans - International Centre for Gerontological Problems "Healthy Ageing"
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Trust/University of Cambridge
Study officials:
affiliation: Cap. Region's Unit of Inherited Cardiac Diseases, Faculty Health&Medical
name: Henning Bundgaard, MD.
role: PRINCIPAL_INVESTIGATOR
References: