Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.

Inclusion Criteria:

1. Age 18 to 90, male and female subject of any race

2. Reverse transcriptase Polymerase Chain Reaction (rt-PCR)-confirmed COVID-19infection based on a nasal / oropharyngeal swab within 10 days before randomization

3. At least one of the following: 1) Respiratory distress with tachypnea (RR ≥ 24breaths/min without oxygen); 2) Partial arterial oxygen pressure (PaO2) / Fractionof inspiration O2 (FiO2), P/F >100 and <300 mmHg (1mmHg = 0.133kPa), 3) SpO2 ≤ 94%while breathing ambient air. Calculation through validated Sat/FiO2 scales is allowed. P/F value of reference ifthe last available before the signature of consent.

4. Need of supplemental oxygen (i.e. new use of supplemental oxygen, or increasedoxygen requirement if on chronic oxygen) requiring low- or high-flow oxygen ornon-invasive mechanical ventilation (7-point WHO-OS category 4 or 5).

5. Radiological chest imaging (X-rays, CT scan) confirms lung involvement andinflammation.

Exclusion Criteria:

1. Cannot obtain informed consent.

2. Hepatic dysfunction with Child Pugh score B or C, or ALT or AST> 5 times the upperlimit.

3. Renal dysfunction with estimated glomerular filtration rate (MDRD) < 50 mL/min/1.73m2 or patient receiving continuous renal replacement therapy, hemodialysis, orperitoneal dialysis.

4. Bacterial sepsis (besides COVID-19 sepsis).

5. Known congenital or acquired immune deficiency.

6. Positive or missing pregnancy test before first drug intake or day 1; pregnant orlactating women; women of childbearing potential and fertile men who do not agree touse at least one primary form of contraception for the duration of the study.