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

SARS Pneumonia Clinical Trial

Official title:

Tocilizumab (RoActemra) as Early Treatment of Patients Affected by SARS-CoV2 (COVID-19) Infection With Severe Multifocal Interstitial Pneumonia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04315480
• Other study ID #: TOCICOV-1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 12, 2020
• Est. completion date: May 2020

Study information

• Verified date: April 2020
• Source: Università Politecnica delle Marche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: May 2020
• Est. primary completion date: April 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• SARS Pneumonia

Intervention

Drug:
• Tocilizumab
single intravenous administration 8mg/Kg

Locations

Country	Name	City	State
Italy	Università Politecnica delle Marche	Ancona	AN

Sponsors (2)

Lead Sponsor	Collaborator
Università Politecnica delle Marche	Azienda Ospedaliera Ospedali Riuniti Marche Nord

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. Review. — View 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 Feb 28. pii: S1556-0864(20)30132-5. doi: 10.1016/j.jtho.2020.02.010. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	need of oro-tracheal intubation	rate of patients needed of intubation	+7 days
Secondary	death	rate of patients dead	14days