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Trial - IRCT20100601004076N26


Column Value
Trial registration number IRCT20100601004076N26
Full text link
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iraj Ghadiminejad

Contact
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

iraj@gnpau.com

Registration date
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-10-23

Recruitment status
Last imported at : July 23, 2022, 1:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Exclusion criteria
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Number of arms
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Ghadiminezhad Daru

Inclusion age min
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate disease at enrollment

Severity scale
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

3: Moderate disease at enrollment

Total sample size
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

200

primary outcome
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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)

Notes
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Oct. 24, 2021, 12:31 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"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"}]