Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 (APN01-COVID-19)

Apeiron Biologics

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Physiological saline solution; Drug: RhACE2 APN01

Study type: Interventional

Funder types: Industry

Identifiers

NCT04335136

APN01-01-COVID19

Details and patient eligibility

About

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

Enrollment: 185 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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185 participants in 2 patient groups, including a placebo group

Group A (active) APN01

Active Comparator group

Description:

Recombinant human angiotensin-converting enzyme 2 (rhACE2) - APN01

Treatment:

Drug: RhACE2 APN01

Group B (placebo control)

Placebo Comparator group

Treatment:

Drug: Physiological saline solution