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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04315480
Recruitment Status : Unknown
Verified April 2020 by Armando Gabrielli, Università Politecnica delle Marche.
Recruitment status was:  Active, not recruiting
First Posted : March 19, 2020
Last Update Posted : April 13, 2020
Sponsor:
Collaborator:
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Information provided by (Responsible Party):
Armando Gabrielli, Università Politecnica delle Marche

Study Description
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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.

Condition or disease Intervention/treatment Phase
SARS Pneumonia Drug: Tocilizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Simon's Two-stages Optimal Design
Masking: None (Open Label)
Masking Description: Radiologist will be blinded for sequence
Primary Purpose: Treatment
Official Title: Tocilizumab (RoActemra) as Early Treatment of Patients Affected by SARS-CoV2 (COVID-19) Infection With Severe Multifocal Interstitial Pneumonia
Actual Study Start Date : March 12, 2020
Estimated Primary Completion Date : April 9, 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: tocilizumab Drug: Tocilizumab
single intravenous administration 8mg/Kg


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. need of oro-tracheal intubation [ Time Frame: +7 days ]
    rate of patients needed of intubation

  2. death [ Time Frame: 14days ]
    rate of patients dead


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315480


Locations
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Italy
Università Politecnica delle Marche
Ancona, AN, Italy, 60020
Sponsors and Collaborators
Università Politecnica delle Marche
Azienda Ospedaliera Ospedali Riuniti Marche Nord
  Study Documents (Full-Text)

Documents provided by Armando Gabrielli, Università Politecnica delle Marche:
Study Protocol  [PDF] March 15, 2020

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Armando Gabrielli, Full Professor Internal Medicine, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT04315480    
Other Study ID Numbers: TOCICOV-1
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Armando Gabrielli, Università Politecnica delle Marche:
Tocilizumab
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases