CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals
CORONA
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
1 other identifier
interventional
596
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedStudy Start
First participant enrolled
November 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedDecember 17, 2020
May 1, 2020
1.1 years
May 22, 2020
December 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital mortality or discharge to hospice
In-hospital mortality or discharge to hospice at Day 60.
60 days
Secondary Outcomes (9)
Adverse Events and Serious Adverse Events
60 days
Change in SpO2
60 days
Hospital free days
60 days
Admission to ICU
60 days
Intubation and mechanical ventilation
60 days
- +4 more secondary outcomes
Study Arms (2)
Prone Positioning (PP)
EXPERIMENTALThe 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.
Control - usual management
NO INTERVENTIONThe control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Alberta Health servicescollaborator
Study Sites (4)
Peter Lougheed Centre (PLC)
Calgary, Alberta, T1Y 6J4, Canada
Foothills Hospital Intensive Care Unit
Calgary, Alberta, T2N 2T9, Canada
Rockyview General Hospital
Calgary, Alberta, T2V 1P9, Canada
South Health Campus
Calgary, Alberta, T3M 1M4, Canada
Related Publications (1)
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.
PMID: 34425072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ken Parhar, MD, MSc
University of Calgary
- PRINCIPAL INVESTIGATOR
Jason Weatherald, MD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Intensivist & Clinical Assistant Professor
Study Record Dates
First Submitted
May 22, 2020
First Posted
May 27, 2020
Study Start
November 10, 2020
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
December 17, 2020
Record last verified: 2020-05