Tocilizumab for SARS-CoV2 (COVID-19) Severe Pneumonitis
NCT ID: NCT04315480
Last Updated: 2020-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
38 participants
INTERVENTIONAL
2020-03-12
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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tocilizumab
Tocilizumab
single intravenous administration 8mg/Kg
Interventions
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Tocilizumab
single intravenous administration 8mg/Kg
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe heart failure
* Bacterial Infection
* Haematological neoplasm
* Neutrophil count below 1000/mcl
* Platelet count below 50000/mcl
* ALT\> x5UNL
* Inability to give informed consent
18 Years
90 Years
ALL
No
Sponsors
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Azienda Ospedaliera Ospedali Riuniti Marche Nord
UNKNOWN
Università Politecnica delle Marche
OTHER
Responsible Party
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Armando Gabrielli
Full Professor Internal Medicine
Locations
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Università Politecnica delle Marche
Ancona, AN, Italy
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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TOCICOV-1
Identifier Type: -
Identifier Source: org_study_id
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