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Trial - IRCT20151227025726N30


Column Value
Trial registration number IRCT20151227025726N30
Full text link
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Afshin Zarghi

Contact
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

mpd@sbmu.ac.ir

Registration date
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-02-28

Recruitment status
Last imported at : Sept. 11, 2022, 4:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Exclusion criteria
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Number of arms
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahid Beheshti University of Medical Sciences

Inclusion age min
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

60

primary outcome
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

28 days mortality Need for intubation

Notes
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Feb. 28, 2022, 8:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"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"}]