| Trial registration number
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IRCT20151227025726N27 |
Full text link
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/58443
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First author
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Afshin Zarghi
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Contact
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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mpd@sbmu.ac.ir
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Registration date
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-09-25
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Recruitment status
Last imported at : Feb. 20, 2022, 5:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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
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Exclusion criteria
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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
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Number of arms
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Shahid Beheshti University of Medical Sciences
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Inclusion age min
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe/critical disease at enrollment
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Severity scale
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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7: Severe/critical disease at enrollment
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Total sample size
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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primary outcome
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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28 days mortality
Need for mechanical ventilation
Oxyganation rate
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Notes
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Sept. 25, 2021, 3:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "400 mg IV+400mg inhaled after 12h", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "400 mg IV+400mg IV after 12h", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]
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