Trial registration number
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IRCT20080901001165N64 |
Full text link
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/56367
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First author
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Reza Allah-varn
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Contact
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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name@domian.com
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Registration date
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-05-21
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Recruitment status
Last imported at : Sept. 1, 2021, 9 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : May 22, 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 : May 22, 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 : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
The patient/Legal guardian has written consciously and freely consent to participate in the study;
In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital;
Moderate to severe COVID pneumonia
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Exclusion criteria
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Pregnancy
Lactation
The patient is present at another clinical trial at the same time.
Severe renal impairment
Severe hepatic impairment
Severe cardiac impairment
Uncontrolled diabetes
Active infection
Active cancer
Coagulopathy
Primary immunodeficiency syndrome
Allergy to Glurunic acid
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Number of arms
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Ministry of Defense, Department of Health
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Inclusion age min
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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65
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Countries
Last imported at : May 22, 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 : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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180
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primary outcome
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Need to receive ICU service rate (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12)
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Notes
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : May 22, 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 : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 556, "treatment_name": "Guluronic acid (g2013)", "treatment_type": "Others pharmacological treatment", "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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