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Completed

NCT Number: NCT04402879

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

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.

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Key information

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 ARDS Acute Respiratory Distress Syndrome COVID-19 Coronaviridae Infections Coronavirus Infections Hypoxemic Respiratory Failure Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Hospital Intensive Care Unit, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prone positioning (PP)

Procedure

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 outcomes

  1. Hospital mortality or discharge to hospice

    Time frame: 60 days

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services

Registry information

Official study 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

Acronym: CORONA

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 27, 2020
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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