Synopsis

COVI-PRONE Trial is looking to determine the efficacy and safety of awake prone position in patients receiving various modalities of oxygen delivery and the ability to reduce the need for invasive mechanical ventilation compared to no proning.

The COVI-PRONE Trial aims to involve multiple centres internationally to participating in the trial. These centers can be found in Canada, The United States, Saudi Arabia, Kuwait, and Poland. 

COVI-PRONE aims to randomize 400 hypoxic patients with COVID-19 or suspect COVID-19 who are receiving > 40% oxygen by face mask, HFNO, or NIPPV. Patients will be randomized to either the intervention group, receiving awake proning for 8-10 hours daily, or standard of care, receiving no proning.

Inclusion Criteria

1. Adults ≥ 18 years of age.
 

2. 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.
 

3. Hypoxemia that requires ≥ 0.4 FiO2 (i.e. ≥ 40% oxygen) or ≥ 5L nasal cannula.
 

4. Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team.
 

5. Admitted to the ICU or an acute care unit where hemodynamic and respiratory
monitoring is feasible.

1. Endotracheal intubation within 30 days of randomization.

Primary outcome

Exclusion Criteria

We will exclude patients with any of the following:
 

1) Immediate need for intubation as determined by the treating team.
 

2) Decreased level of consciousness (Glasgow Coma Scale score ≤10) ), or significant cognitive
impairment that may interfere with compliance (delirium, dementia)

3) Contraindication to proning, including but not limited to any of the following:
    a) Open chest or abdomen, abdominal surgery (i.e. laparotomy) within the 4 days,
    b) Unstable spine, facial, cervical, femur, or pelvic fractures.
    c) Limited neck mobility or inability to lie prone comfortably. 

    d) Skeletal deformities that interfere with proning.
    e) Complete bowel obstruction.
     f) Active upper gastrointestinal bleeding.
    g) Patient is unlikely/unable to prone, or to be compliant as indicated by the treating team.

 

4) Body mass index 40 kg/m2.
 

5) Pregnancy in the third trimester
 

6) Patient/substitute decision maker (SDM) or caring physician’s refusal to enroll in the study.
 

7) Patients with hemodynamic instability and moderate to high dose of vasopressors
(norepinephrine dose ≥ 0.15 mcg/kg/min or equivalent)

 

8) Intubation is not within patient`s goals of care
 

9) Patient received awake proning session for > 1 day prior to randomization
 

10) Previous intubation within the same hospital admission

Secondary Outcome

1. Mortality at 60 days.
 

2. Days alive and free of invasive mechanical ventilation at 30 days.
 

3. Days alive and free of non-invasive ventilation at 30 days
 

4. Days alive and out of the ICU, censored at 60 days.
 

5. Days alive and out of the hospital, censored at 60 days.
 

6. Complications from proning, which includes any of the following: accidental removal of
intravenous access, hypotension, falls from bed, or pressure ulcers.

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