Trial registration number
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IRCT20200204046369N1 |
Full text link
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/46776
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First author
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Mohsen Moghadami
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Contact
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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moghadami@sums.ac.ir
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Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-04-08
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Recruitment status
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Dec. 8, 2020, 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 : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RT-PCR documented SARS-CoV-2 carriage in a nasopharyngeal and oropharyngeal sample at admission
Age over 18 years old
O2 saturation of less than 92 in room air
Hospitalized patients
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Exclusion criteria
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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A known contraindication to treatment with the steroid
Breastfeeding and pregnant patients
Uncontrolled diabetes mellitus
Uncontrolled hypertension
patients who had previously been treated with steroids for any reason
O2 Saturation of above 92 in room air
Dissatisfaction with the study enrollment
Immunodeficiency disorders
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Number of arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Shiraz University of Medical Sciences
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:37 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. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Oct. 26, 2020, 8:37 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. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe/critical disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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7: Severe/critical disease at enrollment
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Total sample size
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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82
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primary outcome
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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The all-cause mortality in 28 days
Clinical status
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Notes
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Oct. 26, 2020, 8:37 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 : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]
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