| Trial registration number
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IRCT20210225050495N1 |
Full text link
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/54619
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First author
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mohammadali Sahraian
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Contact
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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h-hosami@sina.tums.ac.ir
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Registration date
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-10-01
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Recruitment status
Last imported at : Feb. 9, 2022, 3:12 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
all covid-19 patients admitted to the ICU
Mechanically ventilated patients
within the first 24 hours of intubation
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Exclusion criteria
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
liver enzyme more than 5 times of normal upper limit
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Number of arms
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Tehran University of Medical Sciences
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Inclusion age min
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Oct. 2, 2021, 8 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 : Oct. 2, 2021, 8 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 : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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66
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primary outcome
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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In ICU Mortality Percent
the duration of the mechanical ventilation
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Notes
Last imported at : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Oct. 2, 2021, 8 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 : Oct. 2, 2021, 8 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 779, "treatment_name": "Melatonin", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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