| Trial registration number
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IRCT20180302038915N1 |
Full text link
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/55052
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First author
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Afshin Zarghi
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Contact
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mpajouhesh@sbmu.ac.ir
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Registration date
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-04-05
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Recruitment status
Last imported at : Sept. 16, 2021, 1 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : April 6, 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 : April 6, 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 : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Both genders Age ranging from18 to 80 Y.O. who are admitted in hospital
showing at least one of these criteria: Fever (Oral temperature ≥ 38 ℃) , Respiratory rate >24/min , O2Sat<93% in room air or the Pa02/Fi02 ratio ≤300mgHg
Laboratory (RT-PCR) confirming the infection with 2019-Covid Virus
Lung involvement in CT-Scan less than 50 % ( in compliance with the involvement of moderate COVID19 )
5 ≤days since onset of the COVID19 symptoms ≤10
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Exclusion criteria
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
History of allergic reaction to the drugs used in this clinical trial
in a pregnancy or breast feeding status
test Receipt of any experimental treatment for COVID-19 before hand
Heart rate < 60/min
currently on amiodarone prescription
presence of multi organ failure evidence
in need of mechanical ventilation
estimated glomerular filtration rate < 50 0mL/1.73 m2/min
admitted in ICU ward
who are in shock
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Number of arms
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : April 6, 2021, 1 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 : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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80
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Countries
Last imported at : April 6, 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 : April 6, 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 : April 6, 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 : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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50
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primary outcome
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Time to reach clinical recovery
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Notes
Last imported at : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : April 6, 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 : April 6, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 1219, "treatment_name": "Sofosbuvir", "treatment_type": "Antivirals", "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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