Reparixin in COVID-19 pneumonia
- Conditions
- COVID-19 pneumoniaMedDRA version: 20.0Level: HLGTClassification code 10047438Term: Viral infectious disordersSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001645-40-IT
- Lead Sponsor
- DOMPé FARMACEUTICI S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 159
- 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 <300mmHg (1mmHg = 0.133kPa).
4.Chest imaging confirms lung involvement and inflammation.
5.Inflammatory status as documented by at least one of the following: Lactate dehydrogenase (LDH) > 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- 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)<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): -Secondary Endpoints:<br>oChanges in clinical severity score (as recommended by the World Health Organization –WHO– for COVID studies) <br>oDyspnea severity (Liker scale and VAS scale)<br>oChanges in body temperature<br>oChanges in hematology test values<br>oDuration and quantity of supplemental oxygen treatment<br>oIncidence and duration of mechanical ventilation use<br>oIncidence of intensive care unit (ICU) admission need<br>oLung damage extension changes from baseline (assessed by Chest CT or Rx)<br>oChange from baseline in lung exudation degree (assessed by Chest CT or Rx)<br>oPaO2<br>oSpO2<br>oPartial arterioral oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio<br>oCRP<br>oHs-CRP; -Exploratory Endpoints (not mandatory):<br>oCytokine profile<br>oConcentration of Reparixin in serum over time<br>oSARS-CoV-2 virologic counts; -Safety Endpoints:<br>oAdverse events<br>oSerious adverse events;Timepoint(s) of evaluation of this end point: -; -; -