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Trial - IRCT20200426047212N2


Column Value
Trial registration number IRCT20200426047212N2
Full text link
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mehdi Ahmadi Moghadam

Contact
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

ahmadi-m@ajums.ac.ir

Registration date
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-11-11

Recruitment status
Last imported at : March 6, 2022, 10:12 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

informed written desire and consent to participate in the study Age 18 years or older Hospitalization Severe disease Positive polymerase chain reaction (PCR) test Lung involvement based on CT scan

Exclusion criteria
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Death of the patient Physician's diagnosis of not participating in the study History of thrombosis or current thrombosis Suppression of the known immune system Pregnancy and lactation Use of angiotensin converting inhibitors Severe renal, hepatic, respiratory and cardiovascular insufficiency Consumption of cytotoxic drugs Transfer to another hospital

Number of arms
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Ahvaz University of Medical Sciences

Inclusion age min
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

60

primary outcome
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Lactate Dehydrogenase Blood Urea Nitrogen Creatinine Alanine Aminotransferease Aspartate Aminotransferase Alkaline Phosphatase C-Reactive Protein White Blood Cell Neutrophil lymphocytus Red Blood Count Erythrocyte Sedimentation Rate

Notes
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 2/Phase 3

Arms
Last imported at : Nov. 11, 2021, 4:35 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 1300, "treatment_name": "Tofacitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]