COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001172-15/DK

APEIRON Biologics AG - Sponsor

sonja.hoeller@apeiron-biologics.com

2020-03-23

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Hospitalised male or female, ≥ 18 to ≤ 80 years of age at the time of consent. The date of signing informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit. 2. Diagnosed to be COVID-19 POSITIVE (SARS-CoV-2 nucleic acid – qPCR) 3. Oxygenation criterion Oxygen saturation ≤93 % (either on Room Air or while the patient is on supplement oxygen) 4. ALT < 5xULN, bilirubin ≤ 1.5xULN 5. Signed informed consent form

1. Any patient for whom the investigator does not consider there is a reasonable expectation that they will be able to complete the study. 2. Known history of positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody 3. Current or chronic history of liver disease (Child Pugh score ≥ 10), or known hepatic or biliary abnormalities (with the excep-tion of Gilbert's syndrome or asymptomatic gallstones). 4. The patient has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). 5. Patients requiring high doses of loop diuretics (i.e. > 240 mg fu-rosemide daily) with significant intravascular volume depletion, as assessed clinically. 6. History of sensitivity to any of the study medications, or compo-nents thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. 7. Pregnant females as determined by positive serum or urine hCG test prior to dosing. 8. Lactating females. 9. Unwillingness or inability to follow the procedures outlined in the protocol. 10. Unstable Hemoglobin (Hb < 7) at time of drug infusion (i.e. Hb must be > 7 mg/dL at the time of drug infusion. Transfusion is permitted to increase Hb levels to allow entry into the study. 11. Malignancy or other irreversible condition for which 6 month mortality is estimated to be >50%. 12. Arterial blood pH less than 7.2 or serum HCO3- <15 (if ABG not available) before infusion is started. 13. Known severe chronic pulmonary disease: - known FEV1/FVC less than 45% predicted, or - known chronic hypercapnia (PaCO2 > 45 mmHg) or chronic hypoxemia [(PaO2<55 mmHg) on FiO2 =0.21, or supplemental oxygen therapy prior to this admission], or - known FEV1 <15 ml/kg (e.g. 1L for 70 kg person), or - known radiographic evidence of chronic interstitial infil-tration, or - known hospitalization within the past six months for respiratory failure (PaCO2 > 50 mmHg or PaO2 < 55 mmHg, or oxygen saturation <88% on FiO2 = 0.21) - known chronic restrictive, obstructive, neuromuscular, chest wall, or pulmonary vascular disease resulting in severe exercise restriction (i.e. unable to climb stairs or perform household duties), known secondary polycythemia, severe pulmonary hypertension, or ventilator dependency 14. Known vasculitis with diffuse alveolar hemorrhage 15. Lung transplantation 16. Pre-existing renal failure, i.e. requiring renal replacement ther-apy with hemodialysis or peritoneal dialysis 17. There are other uncontrolled co-morbidities that increase the risks associated with the study drug administration, that are as-sessed by the medical expert team as unsuitable 18. Patient in clinical trials with an IMP for COVID-19 within 30 days before signing informed consent form (ICF) 19. Unstable hemodynamics in the preceding 4 hours (MAP ≤ 65 mmHg, or SAP < 90 mmHg, DAP < 60 mmHg, and vaso-active agents required) 20. Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants), 21. Receive any Angiotensin-Converting-Enzyme inhibitor (ACEi) or renin inhibitor treatment within 7 days before ICF

2

APEIRON Biologics AG

35

80

Austria;Denmark;Germany;Russia;United Kingdom;United States

Severe disease at enrollment

6: Severe disease at enrollment

50

The primary endpoint is a composite endpoint of all cause-death or invasive mechanical ventilation up to 28 days or hospital discharge.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 1077, "treatment_name": "Recombinant human angiotensin-converting enzyme 2 (rhace2)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]