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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04315480

Enrollment

Registered

2020-03-19

Start date

2020-03-12

Completion date

2020-05-31

Last updated

2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS Pneumonia

Keywords

Tocilizumab

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.

Interventions

DRUGTocilizumab

single intravenous administration 8mg/Kg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Radiologist will be blinded for sequence

Intervention model description

Simon's Two-stages Optimal Design

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026