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

• Sponsor: Università Politecnica delle Marche (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04315480
• Collaborator: Azienda Ospedaliera Ospedali Riuniti Marche Nord (Other)
• Enrollment: 38
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 1.6
• Patients Per Site Per Month: 23.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
SARS Pneumonia	Drug: Tocilizumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Simon's Two-stages Optimal DesignSimon'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: Mar 12, 2020
• Anticipated Primary Completion Date: Apr 9, 2020
• Anticipated Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tocilizumab	Drug: Tocilizumab; single intravenous administration 8mg/Kg

Outcome Measures

Primary Outcome Measures

1. arrest in deterioration of pulmonary function [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 [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 [+7 days]

   rate of patients needed of intubation

2. death [14days]

   rate of patients dead

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Università Politecnica delle Marche	Ancona	AN	Italy	60020

Sponsors and Collaborators

• Università Politecnica delle Marche
• Azienda Ospedaliera Ospedali Riuniti Marche Nord

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 15, 2020

More Information

Publications

• 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). pii: E186. doi: 10.3390/pathogens9030186. Review.
• 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. Review.
• 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.
• 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.

• Responsible Party: Armando Gabrielli, Full Professor Internal Medicine, Università Politecnica delle Marche
• ClinicalTrials.gov Identifier: NCT04315480
• Other Study ID Numbers: TOCICOV-1
• First Posted: Mar 19, 2020
• Last Update Posted: Apr 13, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Full Professor Internal Medicine, Università Politecnica delle Marche: Tocilizumab
• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Apr 13, 2020