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: Concentrate for solution for injection/infusion
INN or Proposed INN: REPARIXIN
CAS Number: 266359-83-5
Current Sponsor code: DF1681
Sponsors
DOMPé FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Phase 2 Inclusion Criteria: 1. Age 18 to 90. 2. Confirmed COVID-19 diagnosis 3. At least one of the following: 1. Respiratory distress, RR => 30 breaths/min without oxygen; 2. Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2) >100 normal range, C-reactive protein (CRP) => 100mg/L or IL-6 => 40pg/mL, serum ferritin => 900ng/mL, XDP >20mcg/mL. - Phase 3 Inclusion Criteria: Same as above; other criteria TBD based on Phase 2 outcomes. 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 79 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: - Phase 2/3 Exclusion Criteria: 1. Cannot obtain informed consent. 2. Severe hepatic dysfunction (Child Pugh score => C, or AST> 5 times the upper limit); Severe renal dysfunction (estimated glomerular filtration rate <= 30mL / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. 3. Patients with hypersensitivity to ibuprofen or to more than one non steroidal anti-inflammatory 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) 4. Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment. 5. Pregnant and lactating women and those planning to get pregnant. 6. Participated in other interventional clinical trials with investigational medicinal products, not considered suitable for this study by the researchers. 7. 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 |
|---|---|
| Main Objective: - Phase 2 Study Objectives: efficacy and safety of Reparixin as compared to the control arm in adult patients with severe COVID-19 pneumonia - Phase 3 Study Objectives: efficacy and safety of Reparixin treatment as compared to the control arm in adult patients with severe COVID-19 pneumonia;Secondary Objective: Please refer to protocol;Primary end point(s): - Phase 2 Primary Endpoint: Composite endpoint of clinical events (the patient requires at least one of the following: supplemental oxygen requirement, mechanical ventilation use, admission to Intensive Care Unit (ICU), and use of a rescue medication for any reason) - Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events (the patient dies or requires mechanical ventilation use and/or admission to ICU);Timepoint(s) of evaluation of this end point: - | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Secondary Endpoints: o Changes in clinical severity score (as recommended by the World Health Organization –WHO– for COVID studies) o Dyspnea severity (Liker scale and VAS scale) o Changes in body temperature o Changes in hematology test values o Duration and quantity of supplemental oxygen treatment o Incidence and duration of mechanical ventilation use o Incidence of intensive care unit (ICU) admission need o Lung damage extension changes from baseline (assessed by Chest CT or Rx) o Change from baseline in lung exudation degree (assessed by Chest CT or Rx) o PaO2 o SpO2 o Partial arterioral oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio o CRP o Hs-CRP; - Exploratory Endpoints (not mandatory): o Cytokine profile o Concentration of Reparixin in serum over time o SARS-CoV-2 virologic counts; - Safety Endpoints: o Adverse events o Serious adverse events;Timepoint(s) of evaluation of this end point: -; -; - | — |
Countries
Italy
Contacts
Public ContactFlavio Mantelli
Dompé farmaceutici S.p.A.
Outcome results
None listed