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

Evaluation of Efficacy and Safety of Inhaled Tocilizumab in Comparison with Intravenous Tocilizumab in Hospitalized Patients with COVID-19

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151227025726N27

Enrollment

100

Registered

2021-09-25

Start date

2021-09-23

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 pneumonia. U07.1

Interventions

Intervention 1: Case group: At first receive 400 mg tocilizumab by intravenous infusion during one hour. After 12 hours, 400 mg tocilizumab (Temziva, Cinnagen) will be administered by nebulization met

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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 50% or respiratory rate >30 CRP > 75 mg/l IL-6 > 15 pg/ml

Exclusion criteria

Exclusion criteria: Allergy to Tocilizumab or one of the components of drug formulations. ANC 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Number 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.	—

Measure

Time frame

Number 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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Jamaati

Shahid Beheshti University of Medical Sciences

hamidjamaati@hotmail.com+98 21 2712 2020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026