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Completed

NCT Number: NCT04350723

Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)

The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults ≥ 18 years of age.
  • Suspected or confirmed COVID-19. Defined as: a positive PCR for SARS CoV-2 or pending PCR results for patients that are suspected to have COVID-19.
  • Hypoxemia on room air (SPO2<90%), and oxygen requirement ≥ 0.4 FiO2 (i.e. ≥ 40% oxygen).
  • Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team.
  • Admitted to the ICU or an acute care bed where hemodynamic and respiratory monitoring is feasible.

Exclusion criteria

  • Immediate need for intubation as determined by the treating team.
  • Decreased level of consciousness (Glasgow Coma Scale score <10), or significant cognitive impairment hat may interfere with compliance (delirium, dementia)
  • Contraindication to proning including, but not limited to any of the following:

Open chest or abdomen, abdominal surgery (i.e. laparotomy) within the 4 days, Unstable spine, facial, cervical, femur, or pelvic fractures. Limited neck mobility or inability to lie prone comfortably Skeletal deformities that interfere with proning. Complete bowel obstruction. Active upper gastrointestinal bleeding. Patient is unlikely/unable to prone, or to be compliant as indicated by the treating team.

  • Body mass index > 40 kg/m2
  • Pregnancy - third trimester.
  • Patient/substitute decision maker or caring physician's refusal to enroll in the study.
  • Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)
  • Intubation is not within patient's goals of care
  • Patient received awake proning session for > 1 day prior to randomization
  • Previous intubation within the same hospital admission

Treatment and study plan

Awake Proning

Procedure

The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.

Primary outcomes

  1. Endotracheal intubation

    Time frame: within 30 days of randomization

    Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.

Secondary outcomes

  1. Mortality

    Time frame: 60 days

    Death

  2. Invasive mechanical ventilation free days

    Time frame: censored at 30 Days

    Number of days not receiving mechanical ventilation

  3. Non-invasive ventilation free days

    Time frame: censored 30 days

    Number of days not receiving non-invasive mechanical ventilation

  4. Days alive and outside ICU

    Time frame: 60 Days

    Number of days alive and outside the ICU

  5. Days alive and outside of hospital

    Time frame: 60 days

    Number of days alive and outside of hospital

  6. Complications from proning,

    Time frame: 30 days

    Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other.

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • King Abdullah International Medical Research Center
  • McMaster University

Registry information

Official study title

Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial

Acronym: COVI-PRONE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2020
Registry last updated
Oct 15, 2021

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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