| Trial registration number
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NCT04867226 |
Full text link
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04867226
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First author
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov
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Aryan MF Jalal
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Contact
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov
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aryan.jalal87@yahoo.com
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Registration date
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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2021-04-30
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Recruitment status
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
1.patients diagnosed clinically or by rt-pcr in nasopharyngeal swab specimens and/ or lung
involvement confirm by computed tomography scan compatible with covid-19patients 2.age
between 18 year and 70 years, 3.body weight > 50 kg, 4.with written informed consent from
patients or relatives.
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exclusion criteria 1 sensitivity to any medications of regimens, 2.e gfr less than 30.
3.pregnancy. 4.malignancy . 5.participating in another clinical study and refusing to
participate in the study at a later date or later, and they are already taking colchicine
for other diseases .
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Exclusion criteria
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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None
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Number of arms
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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Hawler Medical University
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Inclusion age min
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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70
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Countries
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov
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Iraq
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Type of patients
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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Mild/moderate disease at enrollment
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Severity scale
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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2: Mild/moderate disease at enrollment
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Total sample size
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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100
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primary outcome
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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death rate;length of hospital stay;need for invasive mechanical ventilation;need for supplemental oxygen
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Notes
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : May 3, 2021, 9:44 a.m.
Source : ClinicalTrials.gov
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[{"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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