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Study aim
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Determination of efficacy and safety of inhaled tocilizumab versus intravenous tocilizumab
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Design
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A controlled, parallel group, randomised, phase 3 clinical trial on 100 patients. Permuted block randomisation will be used by using Sealedenvelope site. At first, both groups receive 400 mg tocilizumab by intravenous infusion during one hour. After 12 hours, in the case group, 400 mg tocilizumab will be administered by nebulization method (5 cc every 6 hours) and in the control group 400 mg tocilizumab will be administered by intravenous infusion during one hour.
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Settings and conduct
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Dr. Masih Daneshvari Hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Hospitalized patients with confirmed COVID-19 diagnosis (RT-PCR positive) and severe lung involvement (oxygen saturation < 90% or lung involvement >50% or respiratory rate >30)
Exclusion criteria: sensitivity to tocilizumab or one of the components of drug formulation, ANC<500 cells/mm3, Pelatelet<50,000 cells/mm3, hepatic transaminase > 5 times normal range or mild increase in liver transaminases along with signs and symptoms of liver disorder, history of malignancy, diverticulitis, positive procalcitonin and active infection , concurrent use of other rheumatoid therapy medications
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Intervention groups
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At first, both groups will be received 400 mg tocilizumab by intravenous infusion during one hour. After 12 hours, in the case group, 400 mg tocilizumab will be administered by nebulization method (5 cc every 6 hours) and in the control group 400 mg tocilizumab will be administered by intravenous infusion during one hour. Both groups will receive standard diet including ramdesivir, dexamethasone, enoxaparin and supportive therapies.
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Main outcome variables
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Mortality rate, length of hospital stay, need for ICU hospitalization, need for mechanical ventilation, oxygenation