Trial registration number
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IRCT20151226025699N5 |
Full text link
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/55074
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First author
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Alireza Moslem
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Contact
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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info@medsab.ac.ir
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Registration date
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-04-07
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Recruitment status
Last imported at : May 11, 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 8, 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 8, 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 8, 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 8, 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 8, 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 8, 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 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Written consent for participation
Age over 34 years
A diagnosis of COVID-19 based on symptoms such as severe pneumonia, fever, fatigue, dry cough, respiratory distress, and lungs involvement in the computed tomographic (CT) scan according to the doctor's confirmation
Awareness score of at least 3 based on the 15-point Glasgow Coma Score (GCS)
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Exclusion criteria
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Not tendency to participate in the study
Diagnosed cardiovascular and lung diseases which can disturb the study process
A diagnosis of malignant tumors
Recent use of chemotherapy drugs
Having incomplete medical records
Non-compliance with the vitamin A, B, C, D, and E supplementations
Consumption of vitamin A, B, C, D, and E supplementations during the last 3-month before the study
Pregnancy in women
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Number of arms
Last imported at : April 8, 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 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Sabzevar University of Medical Sciences
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Inclusion age min
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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35
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Inclusion age max
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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85
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Countries
Last imported at : April 8, 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 8, 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 8, 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 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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135
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primary outcome
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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White blood cells (WBCs)
Neutrophils
Lymphocytes
Lactate dehydrogenase (LDH)
Creatine phosphokinase (CPK)
Cell blood count (CBC)
C reactive protein
partial pressure of oxygen (PO2)
partial pressure of carbon dioxide
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Notes
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : April 8, 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 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 2233, "treatment_name": "Vitamin a+vitamin b+vitamin c+vitamin d+vitamin e", "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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