| Trial registration number
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NCT04853979 |
Full text link
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04853979
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First author
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Tim Richard Edmund Harris
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Contact
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-04-22
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Recruitment status
Last imported at : Aug. 5, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : April 24, 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 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : June 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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inclusion criteria: - all adults with suspected or confirmed covid-19 and hypoxemia
respiratory failure.
- spo2 less than 94% or oxygen requirment of more than 5 liters.
- requiring oxygen therapy in hospital< 24 hours
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Exclusion criteria
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- clinical assessment for immediate intervention.
- pf<50
- sf<90
- rr>60bpm
- hemodynamics instability with need for vasopressors.
- msof
- age<18
- pregnancy
- impaired loc, agitation or lack of cooperative patient.
- bmi>40
- unstable spine or pelvis
- abdominal wound
- pnemothorax
- any injury or illness that may be worsened or result in pain as a result of prone
position.
- dnar
- any contraindicaton to prone position.
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Number of arms
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Hamad Medical Corporation
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Inclusion age min
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : June 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Qatar
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Type of patients
Last imported at : April 24, 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 24, 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 : Aug. 5, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
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61
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primary outcome
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Proportion of patients requiring escalation to NIV (CPAP or BIPAP) or IV in each group
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Notes
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "nan", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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