Trial registration number
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IRCT20201015049030N1 |
Full text link
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/51736
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First author
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Mohammad Ali Sahraian
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Contact
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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vcr@tums.ac.ir
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Registration date
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-11-07
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Recruitment status
Last imported at : Dec. 10, 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. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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multi-center
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Study aim
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Outpatients with Covid 19 confirmed by positive PCR test for SARS-CoV-2 or confirmed by abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities),
With blood oxygen saturation between 90-95%
Patients with severe respiratory symptoms such as cough, shortness of breath and severe shortness of breath or CRP above 20 or after three days of standard treatment worsened symptoms of the disease, including exacerbated fevers, aggravated weakness or aggravated shortness of breath based on the physician's clinical judgment
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Exclusion criteria
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Patients with a history of underlying disease such as diabetes, malignancies, renal and heart failure, uncontrolled hypertension, and taking immunosuppressive drugs and corticosteroids
Patients with other active infections
Pregnant or lactating women
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Number of arms
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Nov. 8, 2020, midnight
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 : Nov. 8, 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. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Nov. 8, 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. 8, 2020, midnight
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 : Nov. 8, 2020, midnight
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 : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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200
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primary outcome
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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O2 saturation
Mortality rate
Need for an oxygen therapy
Constitutional
Needs of hospitalization
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Notes
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2
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Arms
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "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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