| Trial registration number
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IRCT20200426047206N4 |
Full text link
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/51687
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First author
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Saeed Bashirian
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Contact
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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s_bashirian@yahoo.com
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Registration date
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-11-01
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Recruitment status
Last imported at : Dec. 21, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Age between 18-75 year
Hospitalized in ward
Confirmed diagnosis with PCR
Elapsed less than 48 hour from symptom onset
Not pregnant or breastfeeding
Do not have moderate to severe liver and renal problems.
Not treated with immunosuppressive drugs during the last 3 months
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Exclusion criteria
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Drug intolerance
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Number of arms
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Hamedan University of Medical Sciences
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Inclusion age min
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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75
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Countries
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate disease at enrollment
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Severity scale
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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3: Moderate disease at enrollment
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Total sample size
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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60
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primary outcome
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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The amount of hospitalization in the intensive care unit during 28 days
Need to oxygen therapy rate
Rate of sleep and depression
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Notes
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Nov. 2, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Nov. 2, 2020, midnight
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": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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