Tocilizumab for SARS-CoV2 (COVID-19) Severe Pneumonitis

Study Overview
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Brief Summary
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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.

Official Title
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Tocilizumab (RoActemra) as Early Treatment of Patients Affected by SARS-CoV2 (COVID-19) Infection With Severe Multifocal Interstitial Pneumonia

Conditions
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SARS Pneumonia

Intervention / Treatment
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* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Simon's Two-stages Optimal Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tocilizumab<br> | Drug: Tocilizumab<br>* single intravenous administration 8mg/Kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arrest in deterioration of pulmonary function | rate of patients with no need in increase of FiO2 to maintain stable SO2 and no need of intubation | 7days | 
| improving in pulmonary function | rate of patients with change of oxygen saturation >3 percentage points or >10% or decrease in FiO2 need or reduction in pulmonary consolidations >30% at HR CT-scan | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need of oro-tracheal intubation | rate of patients needed of intubation | +7 days | 
| death | rate of patients dead | 14days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tocilizumab