| Trial registration number
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IRCT20200406046963N2 |
Full text link
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/55011
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First author
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Ramin Hamidi Farahani
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Contact
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Rgsramin@yahoo.com
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Registration date
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-07-31
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Recruitment status
Last imported at : Sept. 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patient with moderate to severe Covid-19 admitted to ICU
PaO2/FiO2 Less than 300
LDH more than 450
Progression of disease severity and not responding to standard treatment
prediction of intubation for next 24 hours
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Exclusion criteria
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Uncontrolled diabetes mellitus
Active GI bleeding
history of corticosteroid hypersensitivity
sever electrolyte imbalances
Procalcitonin more than 0.5
active bacterial, viral ( HIV, Hepatitis) and fungal infection
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Number of arms
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Artesh University of Medical Sciences
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Inclusion age min
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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90
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Countries
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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40
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primary outcome
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mortality rate
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Notes
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : July 31, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 1807, "treatment_name": "Adalimumab+methylprednisolone", "treatment_type": "Other targeted therapies+corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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