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

April 9, 2020 updated by: Armando Gabrielli, Università Politecnica delle Marche

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AN
      • Ancona, AN, Italy, 60020
        • Università Politecnica delle Marche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: tocilizumab
Drug: Tocilizumab
single intravenous administration 8mg/Kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arrest in deterioration of pulmonary function
Time Frame: 7days
rate of patients with no need in increase of FiO2 to maintain stable SO2 and no need of intubation
7days
improving in pulmonary function
Time Frame: 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
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Politecnica delle Marche

Collaborators

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 12, 2020

Primary Completion (ANTICIPATED)

April 9, 2020

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (ACTUAL)

March 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOCICOV-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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