COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04368000

Stacy A Johnson

Stacy.A.Johnson@hsc.utah.edu

2020-04-29

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - adult (age ≥ 18 years) - suspected or confirmed covid-19 (suspected: high clinical suspicion and pending covid-19 assay; confirmed: positive covid-19 assay within 10 days) - scheduled for admission or already admitted to an inpatient hospital bed - patients must be enrolled within 48 hours of hospital admission

- pregnant - prisoner - contraindication to prone positioning: known increased intracranial pressure >30 mm hg or cerebral perfusion pressure <60 mm hg, increased abdominal pressure or risk for abdominal compartment syndrome, massive hemoptysis requiring urgent intervention, tracheal surgery or sternotomy during previous 14 days, facial surgery or serious facial trauma within 14 days, pacemaker implantation within 48 hours, unstable spine, femur, or pelvic fractures, chest tube, mean arterial pressure less than 65 mm hg - lung transplant - burns on more than 20% of body surface - chronic respiratory failure requiring: mechanical ventilation via endotracheal device (e.g. tracheostomy tube, orotracheal tube, or nasotracheal tube) - inability to change position from supine to prone and prone to supine without assistance - receiving end of life care, comfort measures only, or hospice

2

University of Utah

18

None

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

30

Change in imputed partial pressure of oxygen over fraction of inspired oxygen (PaO2/FiO2) from peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)

None

Not reported

[{"arm_notes": "prone position for a duration of 1-2 hours, every 4 hours while awake.", "treatment_id": 1013, "treatment_name": "Postural positioning", "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"}]