Status:
COMPLETED
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Lead Sponsor:
Apeiron Biologics
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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
- Hospitalized male or female
- Diagnosed to be COVID-19 POSITIV
- Signed Inform Consent Form
Exclusion
- Any patient whose clinical condition is deteriorating rapidly
- Known history of positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody
- 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
- Pregnant females as determined by positive serum or urine hCG test prior to dosing
- Lung transplantation
- Pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis or peritoneal dialysis
- 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
- Patient in clinical trials for COVID-19 within 30 days before ICF
- Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants)
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2020
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT04335136
Start Date
April 30 2020
End Date
December 26 2020
Last Update
August 2 2021
Active Locations (22)
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1
Medizinische Universität Innsbruck
Innsbruck, Austria
2
Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin
Vienna, Austria
3
Medizinische Universität Wien
Vienna, Austria
4
The National University Hospital, Rigshospitalet
Copenhagen, Denmark