Overview

Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19

Status:
Completed
Trial end date:
2020-12-26
Target enrollment:
0
Participant gender:
All
Summary
Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with COVID-19 to block viral entry and decrease viral replication.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Apeiron Biologics
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)