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

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.

Corona Virus Infection

Procedure: Awake Proning

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

Eligibility Criteria

Inclusion Criteria:

1. Adults ≥ 18 years of age.

2. 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.

3. Hypoxemia on room air (SPO2<90%), and oxygen requirement ≥ 0.4 FiO2 (i.e. ≥ 40%

4. Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating

5. Admitted to the ICU or an acute care bed where hemodynamic and respiratory monitoring
is feasible.

Exclusion Criteria:

1. Immediate need for intubation as determined by the treating team.

2. Decreased level of consciousness (Glasgow Coma Scale score <10), or significant
cognitive impairment hat may interfere with compliance (delirium, dementia)

3. 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.

4. Body mass index > 40 kg/m2

5. Pregnancy - third trimester.

6. Patient/substitute decision maker or caring physician's refusal to enroll in the

7. Patients with hemodynamic instability and moderate to high dose of vasopressors
(norepinephrine dose ≥ 0.15 mcg/kg/min)

8. Intubation is not within patient's goals of care

9. Patient received awake proning session for > 1 day prior to randomization

10. Previous intubation within the same hospital admission

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Saudi Arabia
United States

University of Texas Health Sciences Centre
Dallas, Texas, United States

Univeristy of Calgary
Calgary, Alberta, Canada

St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada

Hamilton General Hospital
Hamilton, Ontario, Canada

Juravinski Hospital
Hamilton, Ontario, Canada

St. Catharine's General -
St. Catharines, Ontario, Canada

Sinai Health System
Toronto, Ontario, Canada

University Health Network - Toronto General Hospital
Toronto, Ontario, Canada

CHU de Québec - Université Laval
Quebec, Canada

Al-Amir Hospital
Kuwait, Kuwait

Jaber Al Ahmed hospital
Kuwait, Kuwait

King Fahad Hospital of the University
Khobar, Eastern Province, Saudi Arabia

Prince Mohammed bin Abdulaziz Hospital
Al Madīnah, Saudi Arabia

King Abdulaziz Hospital - NGHA
AlAhsa, Saudi Arabia

King Abdulaziz Medical City - Jeddah
Jeddah, Saudi Arabia

King Abdulaziz Medical City
Riyadh, Saudi Arabia

King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia

St. Joseph's Healthcare Hamilton
NCT Number
MeSH Terms
Coronavirus Infections