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

Primary Purpose

Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prone Positioning (PP)
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Respiratory Syndrome Coronavirus 2 focused on measuring Prone positioning, non-intubated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

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).

Sites / Locations

  • Peter Lougheed Centre (PLC)Recruiting
  • Foothills Hospital Intensive Care UnitRecruiting
  • Rockyview General Hospital
  • South Health Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prone Positioning (PP)

Control - usual management

Arm Description

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.

The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients.

Outcomes

Primary Outcome Measures

Hospital mortality or discharge to hospice
In-hospital mortality or discharge to hospice at Day 60.

Secondary Outcome Measures

Adverse Events and Serious Adverse Events
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
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
Number of hospital free days in the 60 days after enrolment.
Admission to ICU
Admission to the Intensive Care Unit.
Intubation and mechanical ventilation
Patient is intubated and requires mechanical ventilation.
Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Oxygen-free days
The number of oxygen-free days at Day 60 (censored at discharge).
In-hospital death (time)
Time from admission to all-cause in-hospital death.
Death at 90 days
Death at 90 days.

Full Information

First Posted
May 22, 2020
Last Updated
December 14, 2020
Sponsor
University of Calgary
Collaborators
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT04402879
Brief Title
CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals
Acronym
CORONA
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, Acute Respiratory Distress Syndrome, ARDS, Hypoxemic Respiratory Failure
Keywords
Prone positioning, non-intubated

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, unblinded, randomized controlled trial at four (4) medical sites in Calgary, Alberta.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
596 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prone Positioning (PP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - usual management
Arm Type
No Intervention
Arm Description
The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients.
Intervention Type
Procedure
Intervention Name(s)
Prone Positioning (PP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital mortality or discharge to hospice
Description
In-hospital mortality or discharge to hospice at Day 60.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Adverse Events and Serious Adverse Events
Description
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
Time Frame
60 days
Title
Change in SpO2
Description
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).
Time Frame
60 days
Title
Hospital free days
Description
Number of hospital free days in the 60 days after enrolment.
Time Frame
60 days
Title
Admission to ICU
Description
Admission to the Intensive Care Unit.
Time Frame
60 days
Title
Intubation and mechanical ventilation
Description
Patient is intubated and requires mechanical ventilation.
Time Frame
60 days
Title
Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Description
Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Time Frame
60 days
Title
Oxygen-free days
Description
The number of oxygen-free days at Day 60 (censored at discharge).
Time Frame
60 days
Title
In-hospital death (time)
Description
Time from admission to all-cause in-hospital death.
Time Frame
60 days
Title
Death at 90 days
Description
Death at 90 days.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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). 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ken Parhar, MD, MSc
Phone
403-944-0735
Email
ken.parhar@ahs.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Weatherald, MD
Phone
403-943-4779
Email
jcweathe@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Parhar, MD, MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Weatherald, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter Lougheed Centre (PLC)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Weatherald, MD
Facility Name
Foothills Hospital Intensive Care Unit
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Parhar, MD, MSc
Facility Name
Rockyview General Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Solverson, MD
Facility Name
South Health Campus
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry T Stelfox, MD PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34425072
Citation
Weatherald J, Norrie J, Parhar KKS. Awake prone positioning in COVID-19: is tummy time ready for prime time? Lancet Respir Med. 2021 Dec;9(12):1347-1349. doi: 10.1016/S2213-2600(21)00368-4. Epub 2021 Aug 20. No abstract available.
Results Reference
derived

Learn more about this trial

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

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