COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04402879

Ken Parhar, MD, MSc

ken.parhar@ahs.ca

2020-05-27

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - hospitalized patients with probable covid-19. probable is defined as influenza like illness (ili) symptoms or confirmed covid-19 exposure and covid-19 testing performed. ili is defined as any one of the following symptoms including: fever, new or worsening cough, coryza, new or worsening dyspnea, or sore throat. - goals of care are do-not-intubate (r3 or m1/m2 in alberta). - need for oxygen ≥2 l to maintain spo2 ≥92%. if the patient is on long-term oxygen, the o2 requirements must be ≥2 l above their baseline. - patient can be positioned to and from prone to supine with minimal assistance (maximum one person assistance).

- decreased level of consciousness (glasgow coma scale < 10) or precluding ability to self-reposition. - hemodynamic instability (systolic blood pressure < 90 mmhg and or lactate >5 mmol/l or hr >120, not responsive to fluid resuscitation). - complete bowel obstruction. - active upper gastrointestinal bleeding. - poor neck mobility or patient inability to lie prone comfortably. - unstable spine, femur, or pelvic fractures. - pregnancy - third trimester. - full resuscitation status including icu and willingness to accept invasive mechanical ventilation (i.e. r1/r2 goals of care). - imminent palliation or end of life expected on admission (i.e. c1/c2 goals of care).

2

University of Calgary

18

100

Canada

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

596

Hospital mortality or discharge to hospice

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"}]