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| Name | Class |
|---|---|
| Azienda Ospedaliera Ospedali Riuniti Marche Nord | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tocilizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | single intravenous administration 8mg/Kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| need of oro-tracheal intubation | rate of patients needed of intubation | +7 days |
| death | rate of patients dead | 14days |
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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):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Politecnica delle Marche | Ancona | AN | 60020 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32114094 | Background | 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. | |
| 32143502 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2020 | Mar 18, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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Simon's Two-stages Optimal Design
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Radiologist will be blinded for sequence
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| 28466096 | 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. |
| 32113574 | 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. |
| 33307107 | Derived | 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. |