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Trial - IRCT20151226025699N5


Column Value
Trial registration number IRCT20151226025699N5
Full text link
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Dr. Alireza Moslem

Contact
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

info@medsab.ac.ir

Registration date
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-04-07

Recruitment status
Last imported at : May 11, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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)

Exclusion criteria
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Number of arms
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Sabzevar University of Medical Sciences

Inclusion age min
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

35

Inclusion age max
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

85

Countries
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Critical disease at enrollment

Severity scale
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

8: Critical disease at enrollment

Total sample size
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

135

primary outcome
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Notes
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 2/Phase 3

Arms
Last imported at : April 8, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"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"}]