Covid-19 disease
Conditions
Interventions
Trade Name: kineret
Product Name: Anakinra
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg milligra
Sponsors
Centre Hospitalier Intercommunal de Toulon La Seyne-sur-mer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women and men, age = 18 years. Confirmed respiratory tract SARS-coV-2 infection by at least one nasopharygeal sample or bronchoalveolar lavage PCR. Patient hospitalized with clinical, biological and radiological features corresponding to following stages : Stage 2B: corresponds to stage 2A, but with hypoxemia (Sa02 30/min) with biological inflammatory syndrome (CRP>150mg/l) . - Stage 3: ARDS defined as mechanically ventilated patient with PaO2/FiO2 3mg/h • Severe oligo-anuric renal insufficiency or necessitate renal dialysis • Hepatocellular insufficiency or coagulopathy with factor V 5000 ng/mL Social Security affiliation or entitled to universal healthcare cover. Subject or legal representative having expressed written consent after information. 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 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: Pregnant or lactating women Patients transplanted with solid organs or hematopoietic stem cells HIV, HBV or HCV infection Non treated bacterial or mycotic infection Refusal to participate in the study Patient under administrative or judicial supervision Patient on exclusion period from another research Patient receiving psychiatric treatment according to article L3112-1 and L3113-1 which do not apply to article L1121-8 Patient not able to read or understand french language which might prevent him from consenting to participate Any condition which could compromise safety of the patient or interfere in the conduct of the research according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare clinical and biological efficacy of a therapeutic strategy using ANAKINRA with or without RUXOLITINIB for serious cases of SARS-CoV-2 infection, oxygen dependent, needing or not an invasive ventilation on systemic inflammation;Secondary Objective: To compare the efficacy of this strategy on : •The number of days of oxygen dependency •The number of admission in the intensive care for patient of regular unit (Expected result : 20% decrease, admission fall in number from 50% to 30%) •Patients’ mortality at D28 (Expected result : 20% decrease) •Length of stay in the intensive care unit (Expected result : 3 days decrease) •Length of stay in the hospital (Expected result : 3 days decrease) •The evolution of organ failure score SOFA (Expected result : 3 points decrease) •The number of days without fever at D7 (Expected result : 2 days decrease) •The absence of increase on number of bacterial or fungal sepsis of more than 10% ;Primary end point(s): Biological criteria: validation if at least 3 parameters are met including CRP and/or Ferritin 1)CRP : decrease > 50% 2)Ferritinemia : decrease > 1/3 3)Serum creatinine : decrease > 1/3 4)AST/ALT : decrease > 50% 5)Eosinophils > 50 /mm3 6)Lymphocytes > 1000 /mm3 ;Timepoint(s) of evaluation of this end point: D7, D10, D14, D28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - number of days of oxygen dependency - number of admission in the intensive care for patient of regular unit (patient enrolled at stage 2b) - mortality at D28 - number of days in the intensive care unit - total number of days in the hospital - organ failure score SOFA progress - number of days without fever at D7 - number of bacterial or fungal sepsis ;Timepoint(s) of evaluation of this end point: D7, D10, D14, D28 | — |
Countries
France
Contacts
Public ContactAsmaa Jobic
Centre Hospitalier Intercommunal de Toulon La Seyne sur mer
Outcome results
None listed