COVID-19 Pneumonia MedDRA version: 20.0 Level: HLGT Classification code 10047438 Term: Viral infectious disorders System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Reparixin
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: Inclusion Criteria: 1. Age 18 to 90, male and female subject of any race 2. Polymerase Chain Reaction (PCR)-confirmed COVID-19 infection based on a nasal / oropharyngeal swab within 10 days before randomization 3. At least one of the following: 1) Respiratory distress with tachypnea (RR = 24 breaths/min without oxygen); 2) Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2) >100 and normal range, C-reactive protein (CRP) = 100 mg/L or IL-6 = 40 pg/mL, serum ferritin = 900 ng/mL, XDP > 20 mcg/mL. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 103
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Cannot obtain informed consent. 2. hepatic dysfunction with Child Pugh score B or C, or ALT or AST > 5 times the upper limit; 3. renal dysfunction with estimated glomerular filtration rate (MDRD) < 50 mL/min/1.73 m2 or patient receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. 4. Bacterial sepsis (besides COVID-19) 5. Positive test for influenza virus, if tested during the current illness (note: influenza testing is not required by protocol) 6. Known congenital or acquired immune deficiency, 7. Patients with hypersensitivity to ibuprofen or to more than one non-steroidal antiinflammatory drug or to more than one medication belonging to the class of sulfonamides (e.g. sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib; hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole, does not qualify for exclusion). Know allergy to any medication (either investigational or noninvestigational) planned for use in the study. 8. Patients receiving other not allowed medications (see Section: Not allowed medications) 9. Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment. 10. Evidence of COVID-19 disease progression during previously initiated treatment with remdesivir (alone on in any combination with other antiviral treatments), protease inhibitors (e.g. ritonavir, lopinavir, darunavir – atazanavir), tyrosine kinase inhibitors (e.g. baricitinib, imatinib, gefitinib), convalescent plasma or intravenous immunoglobulin for COVID-19, or other investigational treatments 11. More than three infusions of remdesivir, including the loading dose, prior to randomization 12. Pregnant and lactating women. 13. Subject participating in other interventional clinical trials. Subject having received investigational therapy in the previous 3 days, or at least 5 half-lives. 14. At the time of enrollment, patients not in a clinical condition compatible with the oral administration of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Time to the achievement of a composite endpoint based on the following occurrences, up to 28 days (time to first occurrence of any of the following): death, use of invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO), admission to intensive care unit (ICU), use of rescue therapy (see Section: Rescue therapy in thestudy protocol).;Main Objective: Efficacy and safety of Reparixin treatment as compared to placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.;Secondary Objective: NA;Timepoint(s) of evaluation of this end point: Up to 28 days from the start of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoints: - Time to death - Incidence of ICU admission - Time to recovery (category 1 - 2 - 3 of the 7-point WHO Ordinal Scale of clinical improvement (WHO-OS); Additional Secondary Endpoints: o Proportion of subjects achieving the composite endpoint (same as described for the primary end-point) at fixed time-points: days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) after randomization (randomization = day 1), o Mean changes in clinical severity score based on the 7-point WHO-OS o Time to clinical improvement 1 (decline of 1 category in the 7-point WHO-OS) o Time to clinical improvement 2 (decline of 2 categories in the 7-point WHO-OS) o Time to discharge from hospital (up to day 28) o Clinical status at days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) - 60 (±2) either in hospital or at home (7-point WHO-OS). When patient is at home, his/her clinical status can be assessed by phone o Dyspnea severity (Likert scale and VAS scale) at days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge o Duration of supplemental oxygen treatment (days) o Incidence of invasive mechanical ventilation use, or ECMO o Duration of invasive mechanical ventilation, or ECMO (days) o Duration of non-invasive mechanical ventilation (days) o Duration of ICU admission (days) o Duration of hospitalization since randomization (days) o Partial pressure of oxygen (PaO2): change from baseline to the firstly available daily value at days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge o Pulse oximetry by measurement of peripheral arterial oxygen saturation (SpO2) o P/F ratio [partial arteriolar oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio] from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge o Hs-CRP: change from baseline to days 3 - 7 (±1) - 14 (±2) - 21 (±2) - 28 (±2) or until discharge (alternatively, CRP); Exploratory Endpoints: o Time between onset of symptoms and initiation of the investigatio | — |
Countries
Italy
Contacts
Public ContactFlavio Mantelli
Dompé farmaceutici Spa
Outcome results
None listed