| Trial registration number
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IRCT20151227025726N28 |
Full text link
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/58253
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First author
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Afshin Zarghi
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Contact
Last imported at : Oct. 23, 2021, 5:06 a.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 : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-10-21
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Recruitment status
Last imported at : Feb. 19, 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 : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Oct. 23, 2021, 5:06 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. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients above 18 years old
Confirmed COVID-19 (Corona Virus Disease-19) with RT-PCR (Real-Time Polymerase Chain Reaction)
Lung CT scan confirming lung involvement
Hospitalized with SaO2/SPO2≤94% in room air or having Pa02/Fi02 <300mgHg
Becoming symptomatic within the past two weeks
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Exclusion criteria
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Severe liver disease (Child Pugh score ≥ C, AST>10 times upper limit)
Pregnancy
Breastfeeding
Sever renal failure ( estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving dialysis
Drug interactions (Methimazole, chloroquine, hydroxychloroquine)
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Number of arms
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Oct. 23, 2021, 5:06 a.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 : Oct. 23, 2021, 5:06 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. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Oct. 23, 2021, 5:06 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. 23, 2021, 5:06 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 : Oct. 23, 2021, 5:06 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 : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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120
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primary outcome
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Time to clinical improvement
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Notes
Last imported at : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Oct. 23, 2021, 5:06 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 : Oct. 23, 2021, 5:06 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "Remdesivir Veklury 200 mg first day then 100 mg for day 2 to 5", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Remdesivir Ronak Daru 200 mg first day then 100 mg for day 2 to 5", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]
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