COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-006951-32/AT

Dompé farmaceutici s.p.a. - Clinical Trial Manager

cecilia.conz@dompe.com

2022-01-25

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Informed consent signed 2. Male and female adults ≥18 years old 3. Patients hospitalised for clinically suspected CAP, defined as the occurrence of (within 48h from hospital admission): a) at least 1 of the following signs/symptoms: dyspnea, cough, purulent sputum, crackles (rales) and/or rhonchi b) body temperature > 38°C or <36°C (before or during admission) or leukocytosis (> local ULN) c) new/increased pulmonary infiltrate(s) by chest imaging 4. Need for non-invasive supplemental oxygen (NIAID-OS 5-6) 5. SpO2 <92% at room air or PaO2 /FiO2 (or SpO2/FiO2) <300 6. Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception: a) Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives from at least 2 months before the screening visit until 30 days after the last Investigational Medicinal Product (IMP) dose b) A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide from at least 2 months before the screening visit until 30 days after the last IMP dose c) A male sexual partner who agrees to use a male condom with spermicide d) 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

Patients who meet any of the following criteria are NOT eligible for inclusion in the study: 1. Treatment with IMV or ECMO (NIAID-OS 7), 2. Hepatic dysfunction: ALT or AST > 5 ULN, history of chronic hepatic disease (defined with ChildPugh score B or C), 3. Renal dysfunction: estimated glomerular filtration rate (eGFR, MDRD) <50 mL/min/1.73 m2, 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 stop during treatment period (paragraph 5.5.2) 6. Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening 7. History of: a. intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion) b. lactase deficiency, galactosemia or glucose-galactose malabsorption c. gastrointestinal bleeding or perforation due to previous NSAIDs therapy or recurrent peptic ulcer/haemorrhage d. allergy to reparixin or any component of the IMP formulation 8. Active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage 9. Participation in other interventional clinical trials 10. Clinical condition not compatible with oral administration of the study drug 11. Pregnancy: a) positive or missing pregnancy test before first drug intake or day 1, b) pregnant or lactating women, Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study 12. Current hospital stay >72h 13. Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

2

Dompé farmaceutici s.p.a.

18

100

Argentina;Chile;Australia;Austria;Germany;Italy;Turkey;United States

Moderate disease at enrollment

3: Moderate disease at enrollment

14

Proportion of patients dead or requiring IMV (or ECMO) by day 28

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

Phase 3

[{"arm_notes": "New Type treatment : REPARIXIN", "treatment_id": 1105, "treatment_name": "Reparixin", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": null, "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]