| Trial registration number
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IRCT20190804044429N5 |
Full text link
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/54385
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First author
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Majid Saeedi
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Contact
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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majsaeedi@gmail.com
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Registration date
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-02-18
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Recruitment status
Last imported at : March 24, 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 : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
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Allocation
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Feb. 19, 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 : Feb. 19, 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 : Feb. 19, 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 : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Inclusion criteria are adults over the age of 18 with a diagnosis of COVID-19 based on clinical criteria (presence of any symptoms of cough, shortness of breath, fever, and CT scan of the lung for evidence of involvement consistent with COVID-19 infection) or PCR and
Had clinical symptoms of COVID-19 within two weeks
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Exclusion criteria
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Pregnancy and lactation
Severe hepatic insufficiency (Child-pugh C)
Renal insufficiency (GFR less than 30 ml/min)
Allergy history of colchicine
Thrombocytopenia (Platelets less than 100,000 /mm3)
Not consent
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Number of arms
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mazandaran University of Medical Sciences
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Inclusion age min
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : Feb. 19, 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 : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate/severe/critical disease at enrollment
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Severity scale
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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5: Moderate/severe/critical disease at enrollment
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Total sample size
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
110
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primary outcome
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
respiratory rate
blood oxygen saturation
fever recovery
therapeutic regimen safety
CRP
lymphocyte count
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Notes
Last imported at : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Feb. 19, 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 : Feb. 19, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "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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