Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)

Study Overview
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Brief Summary
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The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.

Official Title
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Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial

Conditions
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Corona Virus Infection, Covid19, COVID-19

Intervention / Treatment
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* Procedure: Awake Proning


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A multicenter, parallel-group randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - Awake Proning<br>The oxygen mask or NIPPV or HFNC will be initiated at the treating team's discretion. The patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating oxygen mask or NIPPV or HFNC treatment. Once the patient achieves the above parameters within 15 minutes of initiating oxygen therapy through any modality, the healthcare team will start awake proning. | Procedure: Awake Proning<br>* The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.<br>|
| No Intervention: Control - Standard of Care<br>The patient will receive usual care without proning at the discretion of the treating team. The oxygen mask or NIPPV or HFNC will be initiated, the choice of starting oxygen mask versus NIPPV versus HFNC will be up to the treating team, the patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating NIPPV or HFNC treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal intubation | Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth. | within 30 days of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death | 60 days | 
| Invasive mechanical ventilation free days | Number of days not receiving mechanical ventilation | censored at 30 Days | 
| Non-invasive ventilation free days | Number of days not receiving non-invasive mechanical ventilation | censored 30 days | 
| Days alive and outside ICU | Number of days alive and outside the ICU | 60 Days | 
| Days alive and outside of hospital | Number of days alive and outside of hospital | 60 days | 
| Complications from proning, | Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other. | 30 days |