COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04383613

Michael Fralick, MD, PhD

mike.fralick@mail.utoronto.ca

2020-05-12

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: patients ≥ 18 years of age covid-19 infection is suspected by the treating clinician or confirmed by diagnostic test able to lie on their stomach with verbal instruction requiring supplemental oxygen less than or equal to 50% fio2 capable to make treatment related decisions hospitalized in the last 48 hours with suspected or confirmed covid-19 infection or diagnosed for nosocomial infection in the last 48 hours during their hospital stay

inability to follow commands (e.g., delirium, dementia) indication for mechanical ventilation (e.g., reduced level of consciousness, rapid clinical deterioration) contraindication to prone positioning (spinal cord injury, unstable c-spine, pelvic fracture, unstable airway, open chest or abdomen, anterior chest tube, recent abdominal surgery in past 14 days) patients on home cpap (continue positive airway pressure) transfer from icu in past 72 hours need for telemetry at the time of randomization pregnant (i.e., more than 20 weeks) body mass index above 40 kg/m2 (based on clinician's assessment) recently completed or plan for intrathoracic or intra-abdominal surgical procedure severe hemoptysis pace-maker inserted in past 48 hours

2

Unity Health Toronto

18

None

Canada

Moderate disease at enrollment

3: Moderate disease at enrollment

340

Composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more

None

Not reported

[{"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"}]