| Trial registration number
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ISRCTN16912075 |
Full text link
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.isrctn.com/ISRCTN16912075
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First author
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Keith Couper
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Contact
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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k.couper@warwick.ac.uk
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Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-04-06
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Recruitment status
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Adaptive
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Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : May 14, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Current participant inclusion criteria as of 04/05/2021: 1. Adults =18 years 2. Hospital inpatient with suspected or proven COVID-19 3. FiO2 =0.4 and SpO2 =94% 4. Plan for escalation to intubation if needed Previous participant inclusion criteria: 1. Adults = 18 years 2. Admitted to hospital with suspected or proven COVID-19 3. On 40% oxygen (or greater) with SpO2 <94% 4. Plan for escalation to intubation if needed
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Exclusion criteria
Last imported at : May 14, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Current participant exclusion criteria as of 04/05/2021: 1. Planned intubation and mechanical ventilation imminent within 1 hour 2. Known or clinically apparent pregnancy 3. Any absolute contraindication to CPAP or HFNO 4. Decision not to intubate due to ceiling of treatment or withdrawal of treatment anticipated 5. Equipment for both CPAP and HFNO not available Previous participant exclusion criteria: 1. Planned intubation and mechanical ventilation imminent within 1 hour 2. Known or clinically apparent pregnancy 3. Any absolute contraindication to CPAP or HFNO 4. Decision not to intubate due to ceiling of treatment or withdrawal of care anticipated 5. Equipment for both CPAP and HFNO not available
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Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3
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Funding
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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University of Warwick
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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None
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Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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United Kingdom
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Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Severe disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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4002
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primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Composite outcome comprising tracheal intubation or mortality within 30 days. Mortality will be reported from hospital records up until discharge and tracked after discharge. Intubation will be obtained from hospital data.
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Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (3.0)
differs from found arms (4.0)
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Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 320, "treatment_name": "Continuous positive airway pressure", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 577, "treatment_name": "High flow nasal oxygen", "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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