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Study aim:
Evaluation of Tocilizumab (Actemra) effects on treatment and clinical symptoms and laboratory signs of Iranian COVID-19 patients
Design:
This study is a two arm parallel group, double blinded clinical trial in phase 2 which will be carried out on 40 hospitalized COVID-19 patients. Patients randomly divided into two groups (Control group and Tocilizumab group).
Settings and conduct:
40 hospitalized COVID-19 patients in Shariati and Imam Khomeini hospitals will be included in this study.
Participants/Inclusion and exclusion criteria:
Inclusion Criteria: COVID-19 patient confirmed by positive PCR test for SARS-CoV-19 or abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities), Blood oxygen saturation <93% or respiratory rate> 24, high CRP rate or lymphopenia<1100, and not responding to standard COVID-19 treatment.
Exclusion criteria: A history of malignancies, positive pro-calcitonin and active infection (Including latent or active TB infection), a history of taking immunosuppressive drugs and corticosteroids
Intervention groups:
Control group: Will receive only standard treatment for COVID-19 disease. Tocilizumab group: In addition to standard treatment will receive 8mg/kg Tocilizumab.
Main outcome variables:
Radiographic features findings, Mortality rate, O2 saturation, Need for an oxygen therapy and Laboratory tests