COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN54917435

 Jacob Rosén

Jacob.Rosen@surgsci.uu.se

2020-06-15

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Age 18 year or older 2. Admission to a hospital with confirmed or strongly suspected COVID-19 infection 3. Hypoxic respiratory failure defined as a PaO2/FiO2 ratio = 20 kPa (150 mmHg) and/or a FiO2 of = 0.5 to reach a SpO2 of 94% for more than 1 hour 4. Oxygen supplementation (ongoing or planned) with high flow nasal cannuale or noninvasive ventilating support

1. Severe nasal obstruction or other contraindication to high flow nasal cannulae 2. Patient unable to lay prone or in the face forward position 3. Immediate need for intubation 4. Severe and/or uncontrolled hemodynamic instability 5. Previous intubation for COVID-19 pneumonia (i.e. step down patients) 6. Pregnancy 7. Known terminal illness with life expectancy less than 1 year 8. Decision not to intubate 9. Inability to understand oral or written study information and/or to cooperate with instructions necessary to complete the allocated intervention 10. Inability to understand oral or written study information

2

Uppsala County Council

18

100

Sweden

Severe disease at enrollment

6: Severe disease at enrollment

240

Rate of intubation for mechanical ventilation support; recorded in EHR at inclusion and once if applied. Timeframe 30 days after inclusion.

Not reported

[{"arm_notes": "", "treatment_id": 1751, "treatment_name": "Awake 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"}]