| Trial registration number
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IRCT20200329046892N2 |
Full text link
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/54800
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First author
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Mohammadreza Naghipour
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Contact
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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research@gums.ac.ir
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Registration date
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-03-09
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Recruitment status
Last imported at : June 15, 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 : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : March 10, 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 : March 10, 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 : March 10, 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 : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
All patients with severe Covid-19 admitted to the ICU of Razi Hospital in Rasht for period of March- June 2021
Age greater than or equal to 18 years
Patients admitted with the following criteria: fever (oral temperature greater than 37.2 ° C), dry cough, severe tiredness or dyspnea
At least one of the following criteria : positive PCR OR lung involvement on chest X-ray / CT scan
Absolute lymphocyte count greater than or equal to 200 per cubic millimeter
Absolute neutrophil count greater than or equal to 1000 per milliliter Cubic meters
Hemoglobin above 8 grams per deciliter
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Exclusion criteria
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Lack of informed consent
Lack of patient cooperation
Having pulmonary embolism or intravascular thrombosis
Having another active infection
Having diverticulitis and gastric ulcer
Having tuberculosis or hepatitis B or active hepatitis C or HIV
Any major drug interaction between routine patient's drugs with any of the study drugs
Pregnancy and lactation
Simultaneous presence in other research study
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Number of arms
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Rasht University of Medical Sciences
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Inclusion age min
Last imported at : March 10, 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 : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : March 10, 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 : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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6: Severe disease at enrollment
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Total sample size
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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60
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primary outcome
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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The time required to improve clinical symptoms and within 14 days of treatment start
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Notes
Last imported at : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : March 10, 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 : March 10, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 1300, "treatment_name": "Tofacitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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