APN01-COVID-19

Cause of death or invasive mechanical ventilation (time frame: 28 days)

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

1. LDH level (time frame: day 5)

Log transformed levels of Lactate dehydrogenase (LDH) at day 5 as a   surrogate marker for organ damage (powered secondary endpoint)

2. Mortality (time frame: 28 days)

28-day mortality (all-cause-death)

3. VFD (time frame: 28 days)

Ventilator-free days (VFD) up to 28 days or hospital discharge

4. Time to death (time frame: 28 days)

Time to death (all causes)

1. Hospitalized male or female
2. Diagnosed to be COVID-19 POSITIV
3. Signed Inform Consent Form

1. Any patient whose clinical condition is deteriorating rapidly
2. Known 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 trials for COVID-19 within 30 days before ICF
9. Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants)

Patients will be treated with APN01 or Placebo intravenously twice daily (BID).