| Trial registration number
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IRCT20200411047029N1 |
Full text link
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/55615
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First author
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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hamidreza shekhroshandel
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Contact
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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info@taamasrar.com
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Registration date
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-04-24
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Recruitment status
Last imported at : May 21, 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 25, 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 25, 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 25, 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 25, 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 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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multi-center
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Study aim
Last imported at : April 25, 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 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Age more than 18 years
Definite diagnosis of SARS-CoV-2 virus based on PCR
Diagnosis of pneumonia consistent with lung involvement with COVID-19 on CT scan
Need to be admitted to the ICU at the beginning of hospitalization
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Exclusion criteria
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Having comorbidities (chronic kidney failure, cirrhosis, severe heart failure (less than 25% EF), active or untreated cancer)
Pregnancy and breastfeeding
Patients with hepatic enzymes including aspartate transaminase (AST) and alanine transaminase (ALT) at 5 times more than normal amount
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Number of arms
Last imported at : April 25, 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 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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The Research Institute of Food and Secrets TAAMASRAR
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Inclusion age min
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : April 25, 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 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Critical disease at enrollment
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Severity scale
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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8: Critical disease at enrollment
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Total sample size
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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198
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primary outcome
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Duration and severity of symptoms (cough and shortness of breath)
Duration of hospitalization
Blood oxygen levels
Requirement for ICU admission
Duration of hospitalization in the ICU
Death rate
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Notes
Last imported at : April 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : April 25, 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 25, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 2339, "treatment_name": "Phr-160", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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