Efficacy and Safety of Tocilizumab for Acute Chest Syndrome Treatment in Patients With Sickle Cell Disease

Inclusion Criteria

• •1. SCD patient of all genotypes (SS, SC, S/β0 and S/β+ or other major SCD syndrome)
• •2. Age ≥ 2 years old
• •3. Hospitalized for ACS, defined by the WHO as the association of fever and/or acute respiratory symptoms with a new pulmonary infiltrate on chest imaging, (X-ray, lung ultrasound, or CT scan)
• •4. Requiring supplemental oxygen ≥ 2 L/min for SpO2 ≥ 95% or non-invasive respiratory support (high flow nasal oxygen or continuous positive airway pressure or bilevel non-invasive ventilation) or invasive mechanical ventilation or ECMO, for less than 48 hours
• •5. Negative pregnancy test for girls or women of childbearing age
• •6. Freely given, informed and written consent of patient or legal representatives
• •7. Affiliation to the social security (or health insurance)
• •8. Effective contraception up to 3 months after the administration of treatment (tocilizumab or placebo)
• •2. Known hypersensitivity to tocilizumab or its excipients
• •3. Known active current severe bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster)
• •4. Immunization with a live/attenuated vaccine within the last 4 weeks
• •5. Immunomodulatory therapy, anti-rejection therapy, cell depleting therapies and investigational agents within the last 3 months
• •6. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
• •7. History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions that might predispose a patient to perforations
• •8. Evidence of malignant disease or malignancies diagnosed within the last 3 years
• •9. Pregnancy or breastfeeding
• •10. Imminent and inevitable progression towards death in the opinion of the investigator
• •11. Absolute neutrophil count \< 1.0 G/L or platelets \< 50 G/L
• •12. ALT or AST \> 5-fold the upper limit of normal
• •13. Glomerular Filtration rate (GFR) \< 60 mL/min/1,73 m²
• •14. Current enrolment in another interventional research concerning a medicinal product for human use