| Trial registration number
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IRCT20220508054780N1 |
Full text link
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/63539
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First author
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Benyamin Fazli
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Contact
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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vcreseach@mums.ac.ir
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Registration date
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2022-09-16
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Recruitment status
Last imported at : Jan. 2, 2023, 10:04 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
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Study aim
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients with severe covid 19 who fullfill PCR or radiological criteria for covid 19 clinical symptoms
History of respiratory symptoms from one week before, with a diagnosis of acute respiratory failure
Requires non-invasive ventilation to maintain O2 saturation above 85% in ICU
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Exclusion criteria
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Increased liver enzymes and renal failure
Bacterial, fungal and viral infections
Bone marrow suppression and decrease in leukocytes
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Number of arms
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mashhad University of Medical Sciences
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Inclusion age min
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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0
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Inclusion age max
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Sept. 17, 2022, 7 a.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 : Sept. 17, 2022, 7 a.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 : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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15
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primary outcome
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
The mortality rate of patients with acute respiratory infection of the coronavirus who admitted in ICU
Score of disease severity questionnaire (APACHEII)
Number of days that a patient is on ventilator
Incidence of sepsis
Incidence of respiratory distress
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Notes
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Sept. 17, 2022, 7 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 181, "treatment_name": "Baricitinib", "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"}]
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