| Trial registration number
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IRCT20130812014333N164 |
Full text link
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/52416
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First author
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Farid Najafi
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Contact
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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fnajafi@kums.ac.ir
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Registration date
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-04-01
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Recruitment status
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : April 2, 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 2, 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 2, 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 2, 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 2, 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 2, 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 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Infected patients with Corona virus based on CRISPR test (PCR)
Diagnosis of acute respiratory syndrome according to Berlin criteria
Requires oxygenation or confirmed pneumonia by radiologically or CT
Oxygen uptake concentration
Progression of of pulmonary edema more than 50% within 24-48 hours
Mild to moderate pneumonia caused by a new coronavirus
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Exclusion criteria
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Serious underlying illness or psychosis
Co-infection with HIV, tuberculosis, influenza virus, adenovirus and other viral respiratory infections
Liver or kidney SOFA score more than 3
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Number of arms
Last imported at : April 2, 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 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Kermanshah University of Medical Sciences
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Inclusion age min
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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0
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Inclusion age max
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : April 2, 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 2, 2021, 1 a.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 : April 2, 2021, 1 a.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 : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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8
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primary outcome
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Oxygen saturation
Neutrophil to lymphocyte ratio
Ferritin
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Notes
Last imported at : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : April 2, 2021, 1 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 : April 2, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 788, "treatment_name": "Mesenchymal stem cells exosomes", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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