COVID-19
Conditions
Interventions
Product Name: Repaxirin
Product Code: [DF1681Y]
Pharmaceutical Form: Tablet
INN or Proposed INN: REPARIXIN
CAS Number: 266359-83-5
Current Sponsor code: DF1681Y
Concentration unit: mg milligram(s)
Con
Sponsors
DOMPé FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent signed 2. Male and female > o =18 years old; 3. Patients hospitalized for SARS-CoV-2 infection RT-PCR-confirmed in the previous 10 days; 4. Need for non-invasive supplemental oxygen (NIAID-OS 5-6); 5. Radiological infiltrates by chest imaging; 6. SpO2 =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 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. 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: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the efficacy of oral reparixin plus standard of care versus placebo plus standard of care in limiting disease progression in adult patients hospitalized for severe COVID-19.;Secondary Objective: 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.;Primary end point(s): The primary study endpoint is the proportion of patients requiring IMV (or ECMO) by day 28 [NIAID-OS 7];Timepoint(s) of evaluation of this end point: By day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: The following key secondary endpoints will be considered: 1. Proportion of patients recovered (downward shift from screening of or =1 point of the NIAID-OS) [timeframe: day 28] 3. Ventilatory-free days (VFD) [timeframe: day 28] Number of days from Day 0 to Day 28 when the patient will alive and free of invasive ventilation. In case of multiple periods of IMV during the first 28 days, the total duration of ventilation considered all periods of ventilation during the index admission. Patients who will die within 28 days or will be still on invasive ventilation after 28 days will score zero VFDs. 4. Incidence of secondary infections [timeframe: day 28] o Microbiologically confirmed infections, other than COVID-19, that will develop to day 28 and do not appear to be incubating at the time of inclusion, 5. All-cause mortality [timeframe: day 28] Other secondary endpoints: In addition, the following secondary endpoints will be assessed: - ICU-free days [timeframe: day 28] - Days free of IMV/ECMO (number of days with NIAID-OS 1-5) [timeframe: day 28] - Hospital free days [timeframe: day 28] - Proportion of patients recovered (downward shift from screening of or = 1 point of the NIAID-OS) [timeframe: day 3, 7±1, 14±2, 21±2 or at hospital discharge] - PO2/FiO2 [timeframe: day 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge] - All-cause mortality [day 14 and 60] - Time to discharge or to a NEWS of < or = 2 (for 24 hours), whichever occurs first [timeframe: day 28] - Change in inflammatory markers (LDH, CRP, ferritin; D-dimer) and cytokines [timeframe: baseline - end of treatment];Timepoint(s) of evaluation of this end point: According to the protocol | — |
Countries
Austria, Bulgaria, Germany, Italy, Poland, United States
Contacts
Public ContactClinical Trial Manager
Dompé farmaceutici s.p.a.
Outcome results
None listed