| Trial registration number
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IRCT20210505051197N1 |
Full text link
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/56205
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First author
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr Mohammadreza Naghipour
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Contact
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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research@gums.ac.ir
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Registration date
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-07-18
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Recruitment status
Last imported at : Feb. 18, 2022, 5:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : July 19, 2021, 1:30 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 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RT-PCR test positive for SARS-CoV-2
criteria for patients with moderate symptoms:evidence of lower respiratory disease( dyspnea, Chest compression و..)
oxygen saturation (SpO2) between 90 to 93%
lung infiltrates<50%
criteria for patients with sever symptoms: Dyspnea
respiratory frequency >30 breaths/min
oxygen saturation (SpO2) < 90% and PaO2/FiO2 <300 mm Hg
lung infiltrates >50%
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Exclusion criteria
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
patients with mild symptoms
diabetes
hypertension
pregnant women
those who have already been in clinical trial with other drugs.
Age less than 18 years
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Number of arms
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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3
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Funding
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Rasht University of Medical Sciences
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Inclusion age min
Last imported at : July 19, 2021, 1:30 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 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : July 19, 2021, 1:30 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 19, 2021, 1:30 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 19, 2021, 1:30 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 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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96
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primary outcome
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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C-Reactive Protein serum levels
erythrocyte sedimentation rate serum levels
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Notes
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2/Phase 3
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Arms
Last imported at : July 19, 2021, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "6 mg", "treatment_id": 779, "treatment_name": "Melatonin", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "12 mg", "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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