| Trial registration number
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IRCT20200325046854N2 |
Full text link
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/55085
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First author
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Seyed Abbas Motevalian
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Contact
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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research-m@iums.ac.ir
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Registration date
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-05-03
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Recruitment status
Last imported at : May 5, 2021, 11:36 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Factorial
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Masking
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients with the common type of Novel Coronavirus Pneumonia (NCP) (at high risk) and other severe cases of newly diagnosed coronavirus pneumonia between the ages of 18 and 85 with an increase in IL-6 levels if the patient or his or her judge agrees to participate. Study and after signing the informed consent entered the study. Definition of clinical cases of the novel Coronavirus Pneumonia (NCP) :. 1. Specifications with NCP (with serious risk factors): Contains lung lesions based on common clinical signs of NCP with or without fever. 2. NCP critical patient.
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Exclusion criteria
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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1. Patients participating in other clinical studies 2. Pregnant or lactating women; 3. Patients receiving immunomodulatory drugs to prevent graft rejection or other cases; 4. Allergy to any of the drug compounds; 5. Patients with active pulmonary tuberculosis, with specific bacterial and fungal infections; Patients with malignancy
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Number of arms
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran University of Medical Sciences
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Inclusion age min
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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85
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Countries
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Critical disease at enrollment
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Severity scale
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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8: Critical disease at enrollment
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Total sample size
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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70
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primary outcome
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Evaluation of clinical symptoms
Evaluation of pulmonary CT scan changes
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Notes
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2/Phase 3
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Arms
Last imported at : May 3, 2021, 10:09 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 1963, "treatment_name": "Colchicine+infliximab", "treatment_type": "Metabolic agents+other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 650, "treatment_name": "Infliximab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}]
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