Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia

Inclusion Criteria:

1. Informed consent signed

2. Male and female ≥18 years old;

3. Patients hospitalized for clinically suspected CAP, defined as the occurrence of (within 48h from hospital admission):

4. at least 1 of the following signs/symptoms: dyspnea, cough, purulent sputum,crackles (rales) and/or rhonchi

5. body temperature > 38°C or <36°C (before or during admission) or leucocytosis (> local ULN)

6. new/increased pulmonary infiltrate(s) by chest imaging

7. Need for non-invasive supplemental oxygen (NIAID-OS 5-6; Appendix 14.4.1);

8. SpO2 <92% at room air, or PaO2/FiO2 (or SpO2/FiO2) <300;

9. Females of child-bearing potential and with an active sexual life must not wish toget pregnant within 30 days after the end of the study and must be using at leastone of the following reliable methods of contraception:

10. Hormonal contraception, systemic, implantable, transdermal, or injectablecontraceptives for at least 2 months before the screening visit until 30 daysafter the last IMP dose

11. A non-hormonal intrauterine device [IUD] or female condom with spermicide orcontraceptive sponge with spermicide or diaphragm with spermicide or cervicalcap with spermicide for at least 2 months before the screening visit until 30days after the last IMP dose

12. A male sexual partner who agrees to use a male condom with spermicide

13. A sterile sexual partner

Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake.

Exclusion Criteria:

1. Treatment with IMV or ECMO (NIAID-OS 7);

2. Hepatic dysfunction: ALT or AST > 5 ULN; history of chronic hepatic disease (definedwith Child-Pugh score B or C);

3. Renal dysfunction: estimated glomerular filtration rate (eGFR, MDRD) <50 mL/min/1.73m2, or need for haemodialysis or hemofiltration;

4. Current use of >2 immunosuppressive medications or immunosuppression status (AIDS,aplastic anaemia, asplenia, systemic chemotherapy within the past 3 months,neutropenia (ANC < local LLN), solid organ or bone marrow transplant recipients)

5. Treatment with prohibited medication within 5 half-lives, and inability to stopduring treatment period (see section 5.5.2);

6. Anticipated discharge from the hospital or transfer to another hospital within 72hours of screening

7. History of:

8. intolerance or hypersensitivity to ibuprofen to more than one medicationbelonging to the class of sulfonamides, such as sulfamethazine,sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity tosulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify forexclusion)

9. lactase deficiency, galactosemia or glucose-galactose malabsorption

10. gastrointestinal bleeding or perforation due to previous NSAIDs therapy orrecurrent peptic ulcer/haemorrhage

11. allergy to reparixin or any component of the IMP formulation

12. Active bleeding or bleeding diathesis (excluding menses), prior intracranialhaemorrhage

13. Participation in other interventional clinical trials

14. Clinical condition not compatible with oral administration of the study drug

15. Pregnancy:

16. positive or missing pregnancy test before first drug intake or day 1;

17. pregnant or lactating women;

18. women of childbearing potential and fertile men who do not agree to use atleast one primary form of contraception for the duration of the study

19. Current hospital stay >72h

20. Complicated CAP-associated conditions, such as fungal pulmonary infection,tuberculosis infection, abscess, empyema, significant bilateral pleural effusion,massive pulmonary embolism