Comparison of Inhaled Tocilizumab with Intravenous Tocilizumab in hospitalized patients with COVID-19

Phase 3

Recruiting

Conditions: COVID-19 pneumonia.
U07.1
COVID-19,

Registration Number: IRCT20151227025726N27

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Patients between 18 and 100 years old.
Laboratory confirmed COVID-19 (Corona Virus Disease-19) with RT-PCR (Real-Time Polymerase Chain Reaction) or CT scan.
Have signed the consent form.
O2 saturation < 90% (at room air) or lung involvement >50% or respiratory rate >30
CRP > 75 mg/l
IL-6 > 15 pg/ml

Exclusion Criteria

Allergy to Tocilizumab or one of the components of drug formulations.
ANC < 500 cells/mm
Pelatelet < 50000 cells/mm
Hepatic transaminases > 5 times normal range or mild increase in liver transaminases associated with signs and symptoms of liver disorder
History of malignancy
Diverticulitis
Positive procalcitonin and active infection (including latent or active tuberculosis infection)
Taking other rheumatoid drugs at the same time

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28 days mortality. Timepoint: From the first day of admission until 28 days. Method of measurement: Medical record.;Need for mechanical ventilation. Timepoint: Daily until discharge. Method of measurement: Medical record.;Oxyganation rate. Timepoint: Daily until discharge. Method of measurement: Medical record.

Secondary Outcome Measures

Name	Time	Method
umber of days admitted to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record.;Length of hospital stay. Timepoint: Daily until discharge. Method of measurement: Medical record.;Lung radiological changes. Timepoint: First day of the study then at discharge. Method of measurement: Computed tomography.;Inflammation biomarkers (CRP? IL-6? LDH? Ferritin). Timepoint: Before first dose and 72 hours after second dose. Method of measurement: Medical record.