| Trial registration number
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IRCT20130917014693N13 |
Full text link
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/58520
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First author
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Afshin Zarghi
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Contact
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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mpd@sbmu.ac.ir
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Registration date
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-11-06
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Recruitment status
Last imported at : Jan. 21, 2023, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Age more than 18 years old
Severe acute respiratory injury with coronavirus infection symptoms during 10 days ago who needed for hospital admission
infection with COVID-19 wich confirmed with nasal RT_PCR test or CT-scan imaging
Mild to moderate acute respiratory distress syndrome
No more than 24 hours have passed since their admission to the study.
The patient should not be under aggressive mechanical respiration when entering the study.
Consent to participate in the study.
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Exclusion criteria
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Dissatisfaction of the patient or the patient's legal companion
Pregnancy and lactation
Chronic hemodialysis
Heart failure patients
Severe vasoplegic shock
Pulmonary edema due to other causes like heart failure , cirrhosis, chronic kidney failure
Not administrating corticosteroid more than 24 hours after beginning ARDS
Severe hypoxemia
If the patient expires lower than 3 days after beginning of corticosteroids
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Number of arms
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Shahid Beheshti University of Medical Sciences
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Inclusion age min
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Nov. 7, 2021, 3:03 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 : Nov. 7, 2021, 3:03 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 : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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74
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primary outcome
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mortality ratio of patients with acute respiratory distress syndrome due to covid-19
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Notes
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 1
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Arms
Last imported at : Nov. 7, 2021, 3:03 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "1000 miligrams of methylprednisolone every 24 hours for 3 days then 1 mg/kg every 12 hours for 10 days", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1 mg/kg every 12 hours for 10 days", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]
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