Trial registration number
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IRCT20151227025726N30 |
Full text link
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/61974
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First author
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Afshin Zarghi
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Contact
Last imported at : Feb. 28, 2022, 8:11 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 : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2022-02-28
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Recruitment status
Last imported at : Sept. 11, 2022, 4:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Patients between 18 and 100 years old
Laboratory confirmed COVID-19 with RT-PCR
Be in severe stage of the disease
Have signed the consent to participate in the study
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Exclusion criteria
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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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 to tocilizumab or baricitinib with severe extravasation and symptoms of anaphylactic shock
Mild stage of the disease
Pregnant and lactating patients
Patients who have been intubated
Patients who are expected to die in the next 48 hours
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Number of arms
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Feb. 28, 2022, 8:11 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 : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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60
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primary outcome
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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28 days mortality
Need for intubation
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Notes
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2180, "treatment_name": "Baricitinib+tocilizumab", "treatment_type": "Kinase inhibitors+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]
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