| Trial registration number
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NCT05130541 |
Full text link
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05130541
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First author
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Richard Shin
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Contact
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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2021-11-23
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Recruitment status
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 24, 2021, 8:30 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 : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
age >18
presenting to the ed with symptoms suggestive of covid-19
assessed by ed attending physician to not require emergent intubation
normal mental status and ability to communicate symptoms/distress
able to follow instructions independently
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Exclusion criteria
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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severe respiratory distress requiring immediate intervention
unable to follow verbal instructions
unable to communicate their needs, symptoms, or distress
inability to tolerate prone positioning due to mental status or habitus
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Number of arms
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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New York Hospital Queens
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Inclusion age min
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Nov. 24, 2021, 8:30 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 : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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219
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primary outcome
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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All-cause mortality;Need for intubation
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Notes
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Nov. 24, 2021, 8:30 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non 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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