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

Phase 2

• Conditions: SARS Pneumonia
• Interventions: Drug: Tocilizumab

• Registration Number: NCT04315480
• Lead Sponsor: Università Politecnica delle Marche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-12
• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-19
• Status Verified: 2020-04
• Primary Completion: 2020-04-09
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tocilizumab	Tocilizumab	-

Primary Outcome Measures

Name	Time	Method
arrest in deterioration of pulmonary function	7days	rate of patients with no need in increase of FiO2 to maintain stable SO2 and no need of intubation
improving in pulmonary function	7 days	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

Secondary Outcome Measures

Name	Time	Method
need of oro-tracheal intubation	+7 days	rate of patients needed of intubation
death	14days	rate of patients dead

Trial Locations

Locations (1)

Università Politecnica delle Marche; 🇮🇹 Ancona, AN, Italy