CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals (CORONA)
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|ClinicalTrials.gov Identifier: NCT04402879|
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19 Acute Respiratory Distress Syndrome ARDS Hypoxemic Respiratory Failure||Procedure: Prone Positioning (PP)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||596 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a prospective, unblinded, randomized controlled trial at four (4) medical sites in Calgary, Alberta.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 10, 2020|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: 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.
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.
No Intervention: Control - usual management
The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients.
- Hospital mortality or discharge to hospice [ Time Frame: 60 days ]In-hospital mortality or discharge to hospice at Day 60.
- Adverse Events and Serious Adverse Events [ Time Frame: 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
- Change in SpO2 [ Time Frame: 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 [ Time Frame: 60 days ]Number of hospital free days in the 60 days after enrolment.
- Admission to ICU [ Time Frame: 60 days ]Admission to the Intensive Care Unit.
- Intubation and mechanical ventilation [ Time Frame: 60 days ]Patient is intubated and requires mechanical ventilation.
- Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO). [ Time Frame: 60 days ]Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
- Oxygen-free days [ Time Frame: 60 days ]The number of oxygen-free days at Day 60 (censored at discharge).
- In-hospital death (time) [ Time Frame: 60 days ]Time from admission to all-cause in-hospital death.
- Death at 90 days [ Time Frame: 90 days ]Death at 90 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402879
|Contact: Ken Parhar, MD, MScfirstname.lastname@example.org|
|Contact: Jason Weatherald, MDemail@example.com|
|Peter Lougheed Centre (PLC)||Recruiting|
|Calgary, Alberta, Canada, T1Y 6J4|
|Contact: Jason Weatherald, MD|
|Foothills Hospital Intensive Care Unit||Recruiting|
|Calgary, Alberta, Canada, T2N 2T9|
|Contact: Ken Parhar, MD, MSc|
|Rockyview General Hospital||Not yet recruiting|
|Calgary, Alberta, Canada, T2V 1P9|
|Contact: Kevin Solverson, MD|
|South Health Campus||Not yet recruiting|
|Calgary, Alberta, Canada, T3M 1M4|
|Contact: Henry T Stelfox, MD PhD|
|Principal Investigator:||Ken Parhar, MD, MSc||University of Calgary|
|Principal Investigator:||Jason Weatherald, MD||University of Calgary|