| Trial registration number
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NCT04395105 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04395105
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First author
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Pablo O Rodriguez
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Contact
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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prodriguez@cemic.edu.ar
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-05-20
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Recruitment status
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Terminated
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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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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multi-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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- ards according to berlin's definition
- pcr confirmed covid-19
- length of mechanical ventilation less or equal to 72 hours
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Exclusion criteria
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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- pregnancy or breast-feeding women
- terminal illness with very poor prognosis according to the investigator judgement
- therapeutic limitation
- known immunocompromised condition
- chronic use of systemic corticosteroids
- participation in another randomized crinical trial
- more than 5 days of treatment of low dose dexamethasone for covid-19
- abscence of informed consent
- active participation in other randomized clinical trial
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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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Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
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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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Critical 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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8: Critical disease at enrollment
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Total sample size
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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100
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primary outcome
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Time to successful discontinuation from mechanical ventilation;Ventilator-free days at 28 days
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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 : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "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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