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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402879
• Other study ID #: REB20-0518
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2020
• Source: University of Calgary
• Contact: Ken Parhar, MD, MSc
• Phone: 403-944-0735
• Email: ken.parhar[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 596
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• ARDS
• Coronavirus Infections
• COVID-19
• Hypoxemic Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	Foothills Hospital Intensive Care Unit	Calgary	Alberta
Canada	Peter Lougheed Centre (PLC)	Calgary	Alberta
Canada	Rockyview General Hospital	Calgary	Alberta
Canada	South Health Campus	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital mortality or discharge to hospice	In-hospital mortality or discharge to hospice at Day 60.	60 days
Secondary	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	60 days
Secondary	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).	60 days
Secondary	Hospital free days	Number of hospital free days in the 60 days after enrolment.	60 days
Secondary	Admission to ICU	Admission to the Intensive Care Unit.	60 days
Secondary	Intubation and mechanical ventilation	Patient is intubated and requires mechanical ventilation.	60 days
Secondary	Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).	Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).	60 days
Secondary	Oxygen-free days	The number of oxygen-free days at Day 60 (censored at discharge).	60 days
Secondary	In-hospital death (time)	Time from admission to all-cause in-hospital death.	60 days
Secondary	Death at 90 days	Death at 90 days.	90 days