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

Overview

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.

Full Title of Study: “Tocilizumab (RoActemra) as Early Treatment of Patients Affected by SARS-CoV2 (COVID-19) Infection With Severe Multifocal Interstitial Pneumonia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 9, 2020

Interventions

  • Drug: Tocilizumab
    • single intravenous administration 8mg/Kg

Arms, Groups and Cohorts

  • Experimental: tocilizumab

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Università Politecnica delle Marche
  • Collaborator
    • Azienda Ospedaliera Ospedali Riuniti Marche Nord
  • Provider of Information About this Clinical Study
    • Principal Investigator: Armando Gabrielli, Full Professor Internal Medicine – Università Politecnica delle Marche

References

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.

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.

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.

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.

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