CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals

Not Applicable

• Conditions: ARDS; Hypoxemic Respiratory Failure; COVID-19; Acute Respiratory Distress Syndrome; Severe Acute Respiratory Syndrome Coronavirus 2
• Interventions: Procedure: Prone Positioning (PP)

• Registration Number: NCT04402879
• Lead Sponsor: University of Calgary

Brief Summary

The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.

Detailed Description

As part of the management of COVID-19 related severe ARDS, the World Health Organization (WHO) recommends prone positioned mechanical ventilation. At this time, it is unclear whether there is a role for prone positioning (PP) of non-mechanically ventilated patients.

The objective of this trial is to determine whether PP improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.

Patients randomized to the intervention arm will continue with prone positioning until study inclusion criteria are no longer met, discharge from hospital, day 60 in hospital, or until death or discharge to hospice. Daily assessments will occur until day 60 or until the patient is discharged from hospital or is deceased. The investigators anticipate recruitment to be completed within 12 months of starting the trial.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-27
• Study Start: 2020-11-10
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-17
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 596

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).

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone Positioning (PP)	Prone Positioning (PP)	The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day.

Primary Outcome Measures

Name	Time	Method
Hospital mortality or discharge to hospice	60 days	In-hospital mortality or discharge to hospice at Day 60.

Secondary Outcome Measures

Name	Time	Method
Change in SpO2	60 days	Change in SpO2 during each PP session (SpO2 in prone position - SpO2 prior to prone positioning). Clinicians will be asked to record this change for the first proning session per shift (for 12 hour shifts this will result in 2 proning sessions being documented per 24 hour period, and for 8 hour shifts this will result in 3 proning sessions being documented per 24 hour period).
Hospital free days	60 days	Number of hospital free days in the 60 days after enrolment.
Adverse Events and Serious Adverse Events	60 days	An Adverse Event (AE) is any unfavourable or other finding (including clinically significant laboratory tests), symptom or disease occurring during the during of the study, whether or not it is considered to be related to the medicinal (investigational) product, not explicitly classified elsewhere in this protocol, and whether or not it is expected. A Serious Adverse Event (AE) is any unfavourable medical finding (including clinically significant laboratory tests) at any dose that: * Results in death (primary outcome); * Is life threatening; * Results in persistent of significant disability or incapacity; * Requires in in-patient hospitalisation or prolongation of Hospitalisation
Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).	60 days	Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
In-hospital death (time)	60 days	Time from admission to all-cause in-hospital death.
Death at 90 days	90 days	Death at 90 days.
Oxygen-free days	60 days	The number of oxygen-free days at Day 60 (censored at discharge).
Admission to ICU	60 days	Admission to the Intensive Care Unit.
Intubation and mechanical ventilation	60 days	Patient is intubated and requires mechanical ventilation.

Trial Locations

Locations (4)

Peter Lougheed Centre (PLC); 🇨🇦 Calgary, Alberta, Canada

Rockyview General Hospital; 🇨🇦 Calgary, Alberta, Canada

South Health Campus; 🇨🇦 Calgary, Alberta, Canada

Foothills Hospital Intensive Care Unit; 🇨🇦 Calgary, Alberta, Canada