| Trial registration number
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NCT04834375 |
Full text link
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04834375
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First author
Last imported at : April 14, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Mangala Narasimhan
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Contact
Last imported at : April 14, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : April 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-04-08
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Recruitment status
Last imported at : April 14, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : April 10, 2021, 12:31 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 : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- adults greater or equal than 18 years old
- covid-19 infection confirmed by positive pcr test
- hypoxemia defined by an oxygen saturation < 94% or the need for supplemental oxygen
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Exclusion criteria
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
|
- corticosteroid use for > 48h within the past 15 days prior to enrollment
- use of steroids with doses higher than the equivalent to dexamethasone 6 mg
- use of immunosuppressive drugs
- pregnant women
- chronic oxygen use
- known history of dexamethasone allergy
- dnr / dni
- patient or proxy cannot consent
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Number of arms
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Northwell Health
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Inclusion age min
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : April 10, 2021, 12:31 a.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 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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142
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primary outcome
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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All cause mortality at 28 days
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Notes
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : April 14, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : April 10, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "Weight based dose;0.2 mg/kg/day IV (maximum 20 mg daily) for 10 days", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Standard dose 6 mg IV daily for 10 days", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]
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