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Study aim
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Evaluation of the therapeutic role of plasmapheresis in patients with COVID-19 and its effect on serum levels of inflammatory factors
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Design
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Clinical trial to evaluate the therapeutic effect of plasmapheresis on the severity of the disease and its effect on inflammatory factors in patients without control group and without blinding and randomization, phase 2, will perform on 45 patients with COVID-19 disease.
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Settings and conduct
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A total of 45 patients with COVID-19 admitted to the COVID-19 ward of Shahid Mohammadi Hospital in Bandar Abbas, who are candidates for plasmapheresis, are included in the study. Patients are recorded at the beginning of the study with their clinical history as well as laboratory and radiological findings. Patients then take 5 cc of peripheral blood once before plasmapheresis and once after three periods of plasmapheresis with an interval of one day. Finally, in addition to peripheral and clinical blood parameters according to the questionnaire used, ELISA technique will use to assess the serum levels of cytokines IL-6, IL-1β, TNF-α, IFN-γ.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Increased involvement of more than 50% of the lungs in CT scan - patient with symptoms of severe respiratory failure, patient in need or under mechanical ventilation, patient with multiple organ failure - inadequate response to antiviral and corticosteroid therapy and hypoxia during hospitalization.
Exclusion conditions: Blood pressure below normal range - Coagulation disorders and low platelets below normal range.
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Intervention groups
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The intervention in this study is plasmapheresis in patients with severe COVID-19.
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Main outcome variables
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Blood oxygen level, body temperature, general condition of the patient, evaluation of serum levels of IL-6, IL-1β, TNF-α, IFN-γ, CRP, WBC, before and after plasmapheresis in patients with COVID-19.