| Trial registration number
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IRCT20200506047323N7 |
Full text link
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/54268
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First author
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Teamur Aghamolaei
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Contact
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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mail@hums.ac.ir
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Registration date
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-02-16
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Recruitment status
Last imported at : Aug. 1, 2021, 3 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Definitive diagnosis of COVID-19 based on RT-PCR or/and serological testing,
Age >20 years.
Diagnosis of pneumonia based on pulmonary CT-Scan.
Admitted in the intensive care unit.
Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm.
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Exclusion criteria
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients with underlying disorder, including convulsive disorders, hepatic disease and disorder, renal disease and disorder.
Intubated patients and use of mechanical ventilation.
pregnancy and breastfeeding.
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Number of arms
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Bandare-abbas University of Medical Sciences
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Inclusion age min
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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20
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Inclusion age max
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Feb. 17, 2021, 1 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 : Feb. 17, 2021, 1 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 : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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60
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primary outcome
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Arterial blood gas (ABG)
C-Reactive Protein (C-RP)
Ferritin
Lactate dehydrogenase (LDH)
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Notes
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : Feb. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Feb. 17, 2021, 1 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": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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