Clinical trial NCT04402879: CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals
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
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19
Acute Respiratory Distress Syndrome
ARDS
Hypoxemic Respiratory Failure
Keywords: Prone positioning
non-intubated
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2020-05-27
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, unblinded, randomized controlled trial at four (4) medical sites in Calgary, Alberta.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Hospital mortality or discharge to hospice
timeFrame: 60 days
Secondary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: 60 days
measure: Change in SpO2
timeFrame: 60 days
measure: Hospital free days
timeFrame: 60 days
measure: Admission to ICU
timeFrame: 60 days
measure: Intubation and mechanical ventilation
timeFrame: 60 days
measure: Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
timeFrame: 60 days
measure: Oxygen-free days
timeFrame: 60 days
measure: In-hospital death (time)
timeFrame: 60 days
measure: Death at 90 days
timeFrame: 90 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre (PLC)
state: Alberta
city: Calgary
country: Canada
facility: Foothills Hospital Intensive Care Unit
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ken Parhar, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Jason Weatherald, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.