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

Università Politecnica delle Marche

Status and phase: Unknown; Phase 2

Conditions: SARS Pneumonia

Treatments: Drug: Tocilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04315480

TOCICOV-1

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

tocilizumab

Experimental group

Treatment:

Drug: Tocilizumab