Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
NCT ID: NCT04335136
Last Updated: 2021-08-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2020-04-30
2020-12-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
NCT04287686
Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP Could be Promising Treatment for COVID-19 Infection- and Its Inflammatory Complications Better Than Recombinant Human ACE2
NCT04375046
Compassionate Use of REGN-COV2 for the Treatment of COVID-19
NCT04617535
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19
NCT04507256
Convalescent Plasma in the Treatment of COVID 19
NCT04343261
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A (active) APN01
Recombinant human angiotensin-converting enzyme 2 (rhACE2) - APN01
RhACE2 APN01
Patients will be treated with APN01 intravenously twice daily (BID).
Group B (placebo control)
Physiological saline solution
Patients will be treated with placebo intravenously twice daily (BID).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RhACE2 APN01
Patients will be treated with APN01 intravenously twice daily (BID).
Physiological saline solution
Patients will be treated with placebo intravenously twice daily (BID).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosed to be COVID-19 POSITIV
3. Signed Inform Consent Form
Exclusion Criteria
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)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Apeiron Biologics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henning Bundgaard, MD.
Role: PRINCIPAL_INVESTIGATOR
Cap. Region's Unit of Inherited Cardiac Diseases, Faculty Health&Medical
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Universität Innsbruck
Innsbruck, , Austria
Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin
Vienna, , Austria
Medizinische Universität Wien
Vienna, , 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, , Russia
State Healthcare Institution "State Clinical Hspital № 15 named after O.M. Filatov"
Moscow, , Russia
Moscow State Budgetary Healthcare Institution "City Clinical Hospital №52 of Health Department of Moscow"
Moscow, , Russia
Moscow State Budgetary Healthcare Institution "N.V. Sklifosovsky Research Institute for Emergency Medicine of Health Department of Moscow"
Moscow, , Russia
Saint Petersburg SBHI City Hospital 38 named after N A Semashko
Pushkin, , Russia
Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after I.P. Pavlov" HD RF
Ryazan, , Russia
Alexandrovskaya Hospital
Saint Petersburg, , Russia
Saint-Petersburg State Budget Healthcare Institution City Hospital 15
Saint Petersburg, , Russia
Federal State Budgetary Educational Institution of Higher Education " Saratov State Medical University named after V.I. Razumovsky" HD RF
Saratov, , Russia
Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
Smolensk, , Russia
State budgetary institution of Healthcare of Tver region "Regional clinical hospital"
Tver', , Russia
Yaroslavl Regional Clinical Hospital for Military Veterans - International Centre for Gerontological Problems "Healthy Ageing"
Yaroslavl, , Russia
Cambridge University Hospitals NHS Trust/University of Cambridge
Cambridge, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chene A, Desrames A, Tomlinson A, Ruffie C, Tangy F, Gamain B. An ACE2-Based Bimodular Fusion Protein Enables Reorientation of Endogenous Anti-Epstein-Barr Virus Antibodies Toward SARS-CoV-2 Spike. J Infect Dis. 2023 Dec 20;228(12):1675-1679. doi: 10.1093/infdis/jiad329.
Morrell ED. Tipping the Balance of Ubiquitination toward a Therapy for COVID-19. Am J Respir Cell Mol Biol. 2023 May;68(5):480-481. doi: 10.1165/rcmb.2023-0020ED. No abstract available.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APN01-01-COVID19
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.