Reparixin as add-on Therapy to Standard of Care to Limit Disease Progression in Adult Patients With COVID-19.

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective:

• To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for COVID-19.

Secondary objectives:

• To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality.

Safety objectives:

• To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dompé Farmaceutici S.p.A

Criteria

Inclusion Criteria:

1. Informed consent signed

2. Male and female ≥18 years old;

3. Patients hospitalized for SARS-CoV-2 infection Reverse Transcriptase-Polymerase Chain Reaction-confirmed in the previous 10 days;

4. Need for non-invasive supplemental oxygen (NIAID-OS 5-6);

5. Radiological infiltrates by chest imaging;

6. Peripheral Capillary Oxygen Saturation (SpO2) <94% at room air, or PaO2/FiO2 (Partial pressure of oxygen / Fraction of inspiration oxygen) <300;

7. At least one inflammatory marker above Upper Limit of Normal (ULN) (Lactate dehydrogenase or LDH; C-Reactive Protein or CRP; ferritin; D-dimer);

8. 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:

1. Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last Investigational Medicinal Product dose

2. 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 for at least 2 months before the screening visit until 30 days after the last IMP dose

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

4. 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: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score B or C);

3. Renal dysfunction: estimated glomerular filtration rate (Estimated Glomerular Filtration Rate, Modification of Diet in Renal Disease study equation) <50 mL/min/1.73 m2, or need for haemodialysis or hemofiltration;

4. PaO2/FiO2 ratio < 100 mmHg;

5. Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period;

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

7. History of:

1. 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)

2. lactase deficiency, galactosemia or glucose-galactose malabsorption

3. gastrointestinal bleeding or perforation due to previous NSAIDs therapy or recurrent peptic ulcer/haemorrhage

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:

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

2. 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