COVID-19-associated disease
Conditions
Interventions
Trade Name: Kineret
Pharmaceutical Form: Injection
Trade Name: ROACTEMRA
Pharmaceutical Form: Solution for infusion
Trade Name: JAKAVI
Pharmaceutical Form: Tablet
Sponsors
Assistance Publique Hôpitaux de Marseille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients older than 18 and younger than 75, potentially eligible for admission in ICU -with proven infection with COVID19, using at least one positive pharyngeal polymerase chain reaction (PCR) test -COVID19 infection at stage 2b or 3 -Ability to provide informed consent signed by study patient or legally acceptable representative 1/ Stage 2b: hypoxemia necessitating oxygen therapy>5l/min in order to maintain SpO2>94% (in conventional hospitalization unit or ICU) and CRP>150 mg/l 2/ Stage 3: Moderate or severe ARDS necessitating invasive mechanical ventilation with a PaO2/FiO23mg/h -Myocarditis with cardiogenic shock -Oligo-anuric acute renal insufficiency or requirement for extrarenal epuration -Hemophagocytic syndrome associated with blood cytopenia or hyperferritinemia>5000 micrograms/l 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: -Patients younger than 18 or older than 75 -non-eligible for ICU -Patients without legal rights -No personal or familial consent -Ongoing pregnancy -Patient being treated for Anakinra, tocilizumab, or ruxolitinib for an underlying condition. - Patient already included in another therapeutic trial to modulate inflammation -Uncontrolled bacterial or fungal infection -Hypersensitivity to anakinra -Hypersensitivity to tocilizumab - hypersensitivity to ruxolitinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the therapeutic efficacy of anakinra or tocilizumab alone or in combination with ruxolitinib in severe (2b and 3) forms of COVID-19. The primary outcome criteria is ventilation free days at D28 (VFD28). ;Secondary Objective: Evaluate the therapeutic efficacy of anakinra or tocilizumab alone or in combination with ruxolitinib in severe (2b and 3) forms of COVID-19 on: Number of patients admitted in ICU (for stage 2b) Number of days in ICU (for stage 3) Death at D28 for all patients Number of days in hospital Time to oxygenation weaning Visceral insufficiency improvement (SOFA score) Number of days without fever at D7 (without antipyretics for 48h) No increase in the number of bacteriamia or fungemia Time to improvement of biological inflammatory markers (C reactive protein, fibrinogen, ferritinemia) Time to improvement of biological markers (blood cells counts, creatininemia, transaminases, LDH, gGT, coagulation tests) Improvement of blood cytokine concentrations and NLRP3 constituents Blood concentrations of tocilizumab and search for acquired circulating anti-tocilizumab inhibitory antibodies Lung tomodensitometry and lung ventilation capacity evaluation at D90 after hospitalization exit ;Primary end point(s): ventilation free days at D28 (VFD28) (an increase of 5 days VFD28 is expected);Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Number of patients admitted in ICU (for stage 2b) -Number of days in ICU (for stage 3) -Death at D28 for all patients -Number of days in hospital -Visceral insufficiency improvement (SOFA score) -Number of days without fever at D7 (without antipyretics for 48h) -No increase in the number of bacterial or fungal sepsis -Biological parameters -Immunological parameters -Lung tomodensitometry and ventilation capacity ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
France
Contacts
Public ContactDirection Recherche Santé
Assistance Publique Hôpitaux de Marseille
Outcome results
None listed