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

• Status: Active, not recruiting
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università Politecnica delle Marche
• Collaborator: Azienda Ospedaliera Ospedali Riuniti Marche Nord

Criteria

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