| Trial registration number
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NCT04707534 |
Full text link
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04707534
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First author
Last imported at : March 13, 2022, midnight
Source : ClinicalTrials.gov
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Huimin Wu, MD MPH
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Contact
Last imported at : March 13, 2022, midnight
Source : ClinicalTrials.gov
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Huimin-Wu@ouhsc.edu
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Registration date
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-01-13
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Recruitment status
Last imported at : March 13, 2022, midnight
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Jan. 15, 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 : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- age ≥ 18 years old
- rt-pcr confirmed covid-19 infection
- positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula
(hfnc) or need supplemental oxygen with oxygen mask or nasal cannula
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Exclusion criteria
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- underlying disease requiring chronic corticosteroids
- severe adverse events before admission, i.e. cardiac arrest;
- contraindication for corticosteroids;
- death is deemed to be imminent and inevitable during the next 24 hours
- recruited in other clinical intervention trial
- pregnancy
- patient on judicial protection
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Number of arms
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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University of Oklahoma
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Inclusion age min
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Moderate/severe/critical disease at enrollment
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Severity scale
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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5: Moderate/severe/critical disease at enrollment
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Total sample size
Last imported at : March 13, 2022, midnight
Source : ClinicalTrials.gov
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110
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primary outcome
Last imported at : March 31, 2024, midnight
Source : ClinicalTrials.gov
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Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28
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Notes
Last imported at : Jan. 15, 2021, 12:31 a.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 4
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Arms
Last imported at : Jan. 15, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "6 mg daily for 10 days", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]
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