In a Phase 2 Simon's Optimal Two-Stages Design intravenous tocilizumab will be administered as single 8mg/Kg dose in patients affected by severe multifocal interstitial pneumonia correlated to SARS-CoV2 infection. Aim of the study is to test the hypothesis that an anti-IL6 treatment can be effective in calming the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing naso-tracheal intubation and/or death.
Drug: Tocilizumab
single intravenous administration 8mg/Kg
Inclusion Criteria:
- SARS-CoV2 Infection diagnosed by rt-PCR
- CT-scan confirmed multifocal interstitial pneumonia
- Need of oxygen therapy to maintain SO2>93%
- Worsening of lung involvement, defined as (one of the following criteria):
- Worsening of oxygen saturation >3 percentage points or decrease in PaO2 >10%,
with stable FiO2 in the last 24h
- Need of increase FiO2 in order to maintain a stable SO2 or new onset need of
mechanical ventilation in the last 24h
- Increase in number and/or extension of pulmonary areas of consolidation
Exclusion Criteria:
- Age <18 ys and >90 ys
- Severe heart failure
- Bacterial Infection
- Haematological neoplasm
- Neutrophil count below 1000/mcl
- Platelet count below 50000/mcl
- ALT> x5UNL
- Inability to give informed consent
Università Politecnica delle Marche
Ancona, AN, Italy