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

Università Politecnica delle Marche38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

SARS Pneumonia

Interventions

TocilizumabDRUG

single intravenous administration 8mg/Kg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Università Politecnica delle Marche

Ancona, AN, Italy

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 7 days

Secondary Outcomes

need of oro-tracheal intubation

rate of patients needed of intubation

Time frame: +7 days

death

rate of patients dead

Time frame: 14days

Data from ClinicalTrials.gov

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