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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 : November 27, 2020
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Ken Kuljit Parhar, MD, 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 596 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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, 2020
Estimated Study Completion Date : June 1, 2021


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Hospital mortality or discharge to hospice [ Time Frame: 60 days ]
    In-hospital mortality or discharge to hospice at Day 60.


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. Hospital free days [ Time Frame: 60 days ]
    Number of hospital free days in the 60 days after enrolment.

  4. Admission to ICU [ Time Frame: 60 days ]
    Admission to the Intensive Care Unit.

  5. Intubation and mechanical ventilation [ Time Frame: 60 days ]
    Patient is intubated and requires mechanical ventilation.

  6. 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).

  7. Oxygen-free days [ Time Frame: 60 days ]
    The number of oxygen-free days at Day 60 (censored at discharge).

  8. In-hospital death (time) [ Time Frame: 60 days ]
    Time from admission to all-cause in-hospital death.

  9. Death at 90 days [ Time Frame: 90 days ]
    Death at 90 days.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Ken Parhar, MD, MSc 403-944-0735 ken.parhar@ahs.ca
Contact: Jason Weatherald, MD 403-943-4779 jcweathe@ucalgary.ca

Locations
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Canada, Alberta
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         
Sponsors and Collaborators
University of Calgary
Alberta Health Services
Investigators
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Principal Investigator: Ken Parhar, MD, MSc University of Calgary
Principal Investigator: Jason Weatherald, MD University of Calgary
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Responsible Party: Ken Kuljit Parhar, MD, Consultant Intensivist & Clinical Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT04402879    
Other Study ID Numbers: REB20-0518
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ken Kuljit Parhar, MD, University of Calgary:
Prone positioning
non-intubated
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Lung Injury
Respiratory Tract Infections