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Evaluation of the Effects of Tocilizumab Administration in Hospitalized COVID-19 Patients

Evaluation of the Effects of Tocilizumab Administration in the Cytokine Release Phase on the CT Scan Findings and Clinical Outcomes in Hospitalized COVID-19 Patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151227025726N29
Enrollment
50
Registered
2022-02-16
Start date
2022-02-20
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

COVID-19 pneumonia. COVID-19

Interventions

Intervention group: Dilute 400 mg of ACTEMRA (Tocilizumab) in at least 100 ml of normal saline 0.9 and give it slowly intravenously over at least one hour. The drug should be given at 2 to 8 ° C befor

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients between 18 and 70 years old Laboratory confirmed COVID-19 with RT-PCR Be in severe or critical stage of the disease Have interleukin-6 levels above 15 picogram per milliliter or CRP above 100 miligram per liter

Exclusion criteria

Exclusion criteria: Acute or chronic renal failure (Increase in creatinine by more than 3.0 in the last 48 hours or GFR less than 30 mL/min) Liver failure (more than 5-fold increase in liver enzymes in asymptomatic patients or more than 3-fold increase in liver enzymes in symptomatic patients or Child Pugh C, D) Hypersensitivity reaction during tocilizumbe injection with severe extrusion and symptoms of anaphylactic shock Mild stage of the disease Pregnant and lactating patients Patients with platelets less than 100,000 or ANC less than 5 Patients with Latent TB or Active TB or any active infection History of active gastric ulcer Patients with positive viral marker

Design outcomes

Primary

MeasureTime frame
Mortality. Timepoint: Days 7, 14 and 21 of hospitalization. Method of measurement: Medical record.;Need for intubation. Timepoint: Daily until discharge. Method of measurement: Medical record.;Lung radiological changes. Timepoint: Before receiving tocilizumab and after discharge. Method of measurement: Computed tomography.

Secondary

MeasureTime 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSahar Yousefian

Shahid Beheshti University of Medical Sciences

saahar26@yahoo.com+98 21 2712 2227

Outcome results

None listed

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