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

Primary Purpose

SARS Pneumonia

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
Università Politecnica delle Marche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS Pneumonia focused on measuring Tocilizumab

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Università Politecnica delle Marche

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tocilizumab

Arm Description

Outcomes

Primary Outcome Measures

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

need of oro-tracheal intubation
rate of patients needed of intubation
death
rate of patients dead

Full Information

First Posted
March 14, 2020
Last Updated
April 9, 2020
Sponsor
Università Politecnica delle Marche
Collaborators
Azienda Ospedaliera Ospedali Riuniti Marche Nord
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1. Study Identification

Unique Protocol Identification Number
NCT04315480
Brief Title
Tocilizumab for SARS-CoV2 (COVID-19) Severe Pneumonitis
Official Title
Tocilizumab (RoActemra) as Early Treatment of Patients Affected by SARS-CoV2 (COVID-19) Infection With Severe Multifocal Interstitial Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
April 9, 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Politecnica delle Marche
Collaborators
Azienda Ospedaliera Ospedali Riuniti Marche Nord

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS Pneumonia
Keywords
Tocilizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Simon's Two-stages Optimal Design
Masking
None (Open Label)
Masking Description
Radiologist will be blinded for sequence
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tocilizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
single intravenous administration 8mg/Kg
Primary Outcome Measure Information:
Title
arrest in deterioration of pulmonary function
Description
rate of patients with no need in increase of FiO2 to maintain stable SO2 and no need of intubation
Time Frame
7days
Title
improving in pulmonary function
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
need of oro-tracheal intubation
Description
rate of patients needed of intubation
Time Frame
+7 days
Title
death
Description
rate of patients dead
Time Frame
14days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Università Politecnica delle Marche
City
Ancona
State/Province
AN
ZIP/Postal Code
60020
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32114094
Citation
Tian S, Hu W, Niu L, Liu H, Xu H, Xiao SY. Pulmonary Pathology of Early-Phase 2019 Novel Coronavirus (COVID-19) Pneumonia in Two Patients With Lung Cancer. J Thorac Oncol. 2020 May;15(5):700-704. doi: 10.1016/j.jtho.2020.02.010. Epub 2020 Feb 28.
Results Reference
background
PubMed Identifier
32143502
Citation
Ashour HM, Elkhatib WF, Rahman MM, Elshabrawy HA. Insights into the Recent 2019 Novel Coronavirus (SARS-CoV-2) in Light of Past Human Coronavirus Outbreaks. Pathogens. 2020 Mar 4;9(3):186. doi: 10.3390/pathogens9030186.
Results Reference
background
PubMed Identifier
28466096
Citation
Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
Results Reference
background
PubMed Identifier
32113574
Citation
Zumla A, Ippolito G, Ntoumi F, Seyfert-Margolies V, Nagu TJ, Cirillo D, Chakaya JM, Marais B, Maeurer M. Host-directed therapies and holistic care for tuberculosis. Lancet Respir Med. 2020 Apr;8(4):337-340. doi: 10.1016/S2213-2600(20)30078-3. Epub 2020 Feb 27. No abstract available.
Results Reference
background
PubMed Identifier
33307107
Citation
Sabbatinelli J, Giuliani A, Matacchione G, Latini S, Laprovitera N, Pomponio G, Ferrarini A, Svegliati Baroni S, Pavani M, Moretti M, Gabrielli A, Procopio AD, Ferracin M, Bonafe M, Olivieri F. Decreased serum levels of the inflammaging marker miR-146a are associated with clinical non-response to tocilizumab in COVID-19 patients. Mech Ageing Dev. 2021 Jan;193:111413. doi: 10.1016/j.mad.2020.111413. Epub 2020 Dec 8.
Results Reference
derived

Learn more about this trial

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

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