| Trial registration number
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NCT04328480 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04328480
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First author
Last imported at : April 29, 2021, 10:18 a.m.
Source : ClinicalTrials.gov
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Andres Orlandini, MD
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Contact
Last imported at : April 29, 2021, 10:18 a.m.
Source : ClinicalTrials.gov
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aorlandinimd@eclainternational.org
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-03-31
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Recruitment status
Last imported at : April 29, 2021, 10:18 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Jan. 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria (case definition)
- consented adults (age ≥18 years) and
- covid-19 suspicious and
- admitted to hospital or already in hospital and
- covid-19 suggestive symptoms (fever or febrile equivalent, loss of smell and taste,
fatigue, etc.) that may be present or absent at randomization time and
- sars (severe acute respiratory syndrome)
- shortness of breath (dyspnea) or
- image of typical or atypical pneumonia or
- oxygen desaturation (spo2 ≤ 93)
exclusion criteria
- clear indication or contraindication for the use of colchicine
- pregnant or breastfeeding female.
- chronic renal disease with creatinine clearance <15 ml/min/m2
- negative pcr test for sars-cov2
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Estudios Clínicos Latino América
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Argentina
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : April 29, 2021, 10:18 a.m.
Source : ClinicalTrials.gov
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1279
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primary outcome
Last imported at : Jan. 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Composite outcome: New requirement for mechanical ventilation or death;Mortality
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.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": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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