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

NCT04315480 | Unknown Phase 2

• 1 other identifier: TOCICOV-1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS Pneumonia

Keywords

Tocilizumab

Outcome Measures

Primary Outcomes (2)

• 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

  7days

• 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

  7 days

Secondary Outcomes (2)

• need of oro-tracheal intubation

  +7 days

• death

  14days

Study Arms (1)

tocilizumab

EXPERIMENTAL

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

single intravenous administration 8mg/Kg

tocilizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università Politecnica delle Marche: lead
• Azienda Ospedaliera Ospedali Riuniti Marche Nord: collaborator

Study Sites (1)

Università Politecnica delle Marche

Ancona, AN, 60020, Italy

Location

Related Publications (5)

• 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.

  PMID: 32114094 BACKGROUND

• 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.

  PMID: 32143502 BACKGROUND

• 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.

  PMID: 28466096 BACKGROUND

• 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.

  PMID: 32113574 BACKGROUND

• 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.

  PMID: 33307107 DERIVED

MeSH Terms

Interventions

tocilizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Radiologist will be blinded for sequence
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Internal Medicine

Model Details: Simon's Two-stages Optimal Design

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 19, 2020
• Study Start: March 12, 2020
• Primary Completion: April 9, 2020
• Study Completion: May 1, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)