Trial registration number
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IRCT20200921048786N1 |
Full text link
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/51086
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First author
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Leila Masoudi Yekta
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Contact
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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masoudiyekta@yahoo.com
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Registration date
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-11-11
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Recruitment status
Last imported at : Dec. 20, 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. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Individuals over 18 years of age whose covid-19 disease has been confirmed by PCR test (PCR specification of the test from the Iranian manufacturer - Pishtaz Teb and performed by molecular method) and clinically severely ill
o2sat below 90% despite receiving oxygen
Severe bilateral pulmonary involvement
Satisfaction to participate in the study
Failure to receive any medication other than the standard protocol approved by the National Corona Therapy
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Exclusion criteria
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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History of drug allergies to similar compounds
Pregnancy and lactation
Infection with other microbial or viral infections
History of heart disease
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Number of arms
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Dezfoul University of Medical Sciences
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Inclusion age min
Last imported at : Nov. 12, 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. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Nov. 12, 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. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : Nov. 12, 2020, midnight
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 : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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82
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primary outcome
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Clinical efficacy according to clinical response based on blood oxygen saturation
LDH levels
Duration of hospitalization
Mortality rate
Changes in liver enzymes
Clinical efficacy of treatment regimen based on changes in respiratory rate
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Notes
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 672, "treatment_name": "Interferon beta 1b", "treatment_type": "Interferons", "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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