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

Phase 2

Conditions: COVID-19 disease.
COVID-19, virus not identified
U07.2

Registration Number: IRCT20081027001411N4

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

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%, or respiratory rate> 24
high CRP rate,
lymphopenia < 1100
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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic features Findings. Timepoint: Before treatment and 6 weeks after treatment. Method of measurement: CT scan.;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.

Secondary Outcome Measures

Name	Time	Method
aboratory 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.