Effect of TOCILIZUMAB (ACTEMRA) on treatment of COVID-19

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
INTERVENTION: Intervention 1: Intervention group: Patients hospitalized with COVID‐19 disease will receive 8mg/kg Tocilizumab (Roche) in addition to their standard treatment. If the patients condition is not stable 2 doses by 12 hours will be administrated (maximum dose: 800 mg). Intervention 2: Control group: Patients hospitalized with COVID‐19 disease will receive Half‐normal saline with the standard treatment. CONDITION: COVID‐19 disease. ; COVID‐19, virus not identified U07.2 PRIMARY OUTCOME: Mortality rate. Timepoint: Before and after treatment. Method of measurement: Observation. Need an oxygen therapy. Timepoint: Before and after (at day 5 after treatment and discharge time). Method of measurement: The need on oxygen therapy (Yes or No), If yes: Type of oxygen therapy (nasal cannula, mask oxygen, reserve mask, noninvasive ?ventilation (NIV), and ?invasive ventilation)?. O2 saturation. Timepoint: Before and after (at day 5 after treatment and at discharge time). Method of measurement: Pulse Oximeter. Radiographic features Findings. Timepoint: Before treatment and 6 weeks after treatment. Method of measurement: CT scan. SECONDARY OUTCOME: Laboratory tests (including CBC, Hb, HCT, FBS, TG, Cho, ESR, CRP, VBG, IL‐6, Ferritin, CPK, ALT, AST, Troponin, and D‐dimer). Timepoint: Before and after (at day 5 after treatment and discharge time). Method of measurement: Para‐clinical. INCLUSION CRITERIA: COVID‐19 patients confirmed by positive PCR ?test for SARS‐CoV‐19 or confirmed by abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass ?opacities), with Blood oxygen saturation <93%, with Respiratory Rate >24 breaths/minute, high CRP rate, lymphopenia < 1100 not responding to standard COVID‐19 treatment.
Epistemonikos ID: 7523741cb5b8d327b5f4c15fb943f2cf71f96634
First added on: Jul 10, 2020