COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04350723

Waleed Alhazzani

waleed.al-hazzani@medportal.ca   

2020-04-17

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: adults ≥ 18 years of age. suspected or confirmed covid-19. defined as: a positive pcr for sars cov-2 or pending pcr results for patients that are suspected to have covid-19. hypoxemia on room air (spo2<90%), and oxygen requirement ≥ 0.4 fio2 (i.e. ≥ 40% oxygen). bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team. admitted to the icu or an acute care bed where hemodynamic and respiratory monitoring is feasible.

immediate need for intubation as determined by the treating team. decreased level of consciousness (glasgow coma scale score <10), or significant cognitive impairment hat may interfere with compliance (delirium, dementia) contraindication to proning including, but not limited to any of the following: open chest or abdomen, abdominal surgery (i.e. laparotomy) within the 4 days, unstable spine, facial, cervical, femur, or pelvic fractures. limited neck mobility or inability to lie prone comfortably skeletal deformities that interfere with proning. complete bowel obstruction. active upper gastrointestinal bleeding. patient is unlikely/unable to prone, or to be compliant as indicated by the treating team. body mass index > 40 kg/m2 pregnancy - third trimester. patient/substitute decision maker or caring physician's refusal to enroll in the study. patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min) intubation is not within patient's goals of care patient received awake proning session for > 1 day prior to randomization previous intubation within the same hospital admission

2

St. Joseph's Healthcare Hamilton

18

100

Canada;Kuwait;Saudi Arabia;United States

Severe disease at enrollment

6: Severe disease at enrollment

400

Endotracheal intubation

None

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"}]