NCT04402879

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

A Prospective Randomized Trial of Prone Positioning Versus Usual Care for Patients With Do-not-intubate Goals of Care and Hypoxemic Respiratory Failure During the Coronavirus SARS-CoV-2 (COVID-19) Pandemic

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 596 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Acute Respiratory Syndrome Coronavirus 2
• COVID-19
• Acute Respiratory Distress Syndrome
• ARDS
• Hypoxemic Respiratory Failure

Interventions

Type	Name	Description
PROCEDURE	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 until the occurrence of a primary outcome event or hospital discharge. The target duration (dose) of PP is \> 8 hours per day for up to 60 days, or until oxygen requirements are \< 2 L per minute or \< 2 L per minute above baseline home oxygen requirements.

Timeline

• Start date: 2020-11-10
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2020-05-27
• Last updated: 2020-12-17

Locations

4 sites across 1 country: Canada