The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients
Drug: Tocilizumab
Tocilizumab 8mg/kg D1 and if no response (No decrease of oxygen requirement) a second fixed dose of 400mg wil be administered at D3
Drug: Dexamethasone
Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner)
Inclusion Criteria:
1. Patients included in the CORIMUNO-19 cohort
2. Patients belonging to the following group:
- Requiring ≥ 3L/min of oxygen
- WHO progression scale = 5
- No NIV or High flow
Exclusion Criteria:
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Known hypersensitivity to Tocilizumab or DXM or to any of their excipients.
- Pregnancy
- Current documented bacterial infection not controlled by antibiotics.
- certain evolving viral diseases (especially active herpes, chickenpox, shingles),
- psychotic states still not controlled by treatment,
- live vaccines in the previous 4 weeks,
- Active tuberculosis or disseminated strongyloidiasis
- Patient with any of following laboratory results out of the ranges detailed below at
screening should be discussed depending of the medication:
- Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
- Haemoglobin level: no limitation
- Platelets (PLT) < 50 G /L
- SGOT or SGPT > 5N
CH Andrée Rosemon
Cayenne, French Guiana