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Study aim
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Evaluation of the therapeutic role of plasmapheresis, tocilizumab and the combination of tocilizumab and Plasmapheresis in patients with covid19
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Design
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Clinical trial without control group, with parallel group, double-blind, non randomized, phase 3 on 90 patient
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Settings and conduct
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A total of 90 patients with COVID-19 admitted to the covid19 ward of Yazd Medical Sciences Hospitals who, at the discretion of their treating physician, are candidates for receiving tocilizumab, Plasmapheresis or both. once before and once after the above interventions. Finally, in addition to peripheral and clinical blood parameters according to the questionnaire used, enzyme-linked immunosorbent assay(ELISA) is used to assess the serum levels of cytokines Interleukin 6 (IL-6), Ferritin, procalcitonin, CRP, D Dimer.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age 18 to 65 years, Detection of Covid-19 based on PCR of the nasopharynx, Serum CRP and interleukin 6 levels are at least twice normal, O2sat <80% without supplemental oxygen or RR> 24
Exclusion criteria: History of drug allergy, Platelets less than 50000, Suspected by active viral (Non-COVID), bacterial and fungal infections, Primary intubation, Pregnancy and lactation, Patient or family dissatisfaction
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Intervention groups
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the tocilizumab group will receive two doses of 400 mg of tocilizumab (every 24 hours). in the plasmapheresis group undergo three plasmapheresis sessions every 48 hours. in the tocilizumab and plasmapheresis group will undergo three plasmapheresis sessions every 48 hours after receiving two doses of tocilizumab every 48 hours.
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Main outcome variables
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Blood oxygen level, clinical outcomes, frequency of recovery, serum levels of IL-6, white blood count, Ferritin, procalcitonin, CRP, D Dimer