Trial registration number
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IRCT20100601004076N26 |
Full text link
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/54315
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First author
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iraj Ghadiminejad
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Contact
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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iraj@gnpau.com
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Registration date
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-10-23
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Recruitment status
Last imported at : July 23, 2022, 1:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Informed and voluntary oral and written consent of the patient or his / her guardian to participate in the study
Age over 18 years
SARS-CoV-2 virus PCR test positive or having one of the following conditions: Strong symptoms of COVID-19 disease, including fever, dry cough, and shortness of breath
Existence of CT scan confirming lung involvement, especially ground glass view
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Exclusion criteria
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Individuals whose Covid-19 test has not been approved
Individuals who use drugs
Individuals who drink alcohol
Individuals who use immunosuppressive drugs
Individuals under chemotherapy or radiotherapy
Individuals who use growth hormone, testosterone and anabolic steroids
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Number of arms
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Ghadiminezhad Daru
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Inclusion age min
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate disease at enrollment
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Severity scale
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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3: Moderate disease at enrollment
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Total sample size
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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200
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primary outcome
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Complete Blood Count (CBC), Differentiation
Erythrocyte sedimentation rate (ESR)
C-Reactive Protein (CRP)
Alanine Aminotransferease (ALT)
Aspartate aminotransferase (AST)
Creatinine
Di-Dimer Test
Respiratory Presentations
Weakness and lethargy
Fever
Myalgia
Dry Cough
Existence of sputum
Sore throat
Diarrhea
Shortness of breath
Rhinitis
Nausea
Headache
Shivering
Presence of ground-glass appearance
Alveolar Complication
Unilateral or bilateral pulmonary involvement
Location of Involvement
Presence of Acute respiratory distress syndrome (ARDS)
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Notes
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 2005, "treatment_name": "Endor", "treatment_type": "Vitamins and dietary supplements", "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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