Clinical trial NCT04350723: Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)
Official title: Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corona Virus Infection
Covid19
COVID-19
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: King Abdullah International Medical Research Center
name: McMaster University
name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-04-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, parallel-group randomized controlled trial
Primary purpose: TREATMENT

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.


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% oxygen).
4. Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team.
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 study.
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

Primary outcomes:
measure: Endotracheal intubation
timeFrame: within 30 days of randomization
Secondary outcomes:
measure: Mortality
timeFrame: 60 days
measure: Invasive mechanical ventilation free days
timeFrame: censored at 30 Days
measure: Non-invasive ventilation free days
timeFrame: censored 30 days
measure: Days alive and outside ICU
timeFrame: 60 Days
measure: Days alive and outside of hospital
timeFrame: 60 days
measure: Complications from proning,
timeFrame: 30 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Health Sciences Centre
state: Texas
city: Calgary
country: Canada
facility: Univeristy of Calgary
state: Alberta
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: St. Catharine's General -
state: Ontario
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Quebec
country: Canada
facility: CHU de Québec - Université Laval
city: Kuwait
country: Kuwait
facility: Al-Amir Hospital
city: Kuwait
country: Kuwait
facility: Jaber Al Ahmed hospital
city: Khobar
country: Saudi Arabia
facility: King Fahad Hospital of the University
state: Eastern Province
city: Al Madīnah
country: Saudi Arabia
facility: Prince Mohammed bin Abdulaziz Hospital
city: AlAhsa
country: Saudi Arabia
facility: King Abdulaziz Hospital - NGHA
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City - Jeddah
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Waleed Alhazzani
role: PRINCIPAL_INVESTIGATOR
affiliation: King Saud Bin Abdulaziz University for Health Sciences
name: Yaseen Arabi
role: PRINCIPAL_INVESTIGATOR
affiliation: King Faisal Specialist Hospital and Research Center, Jeddah
name: Zainab Alduhailib
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alhazzani W, Parhar KKS, Weatherald J, Al Duhailib Z, Alshahrani M, Al-Fares A, Buabbas S, Cherian SV, Munshi L, Fan E, Al-Hameed F, Chalabi J, Rahmatullah AA, Duan E, Tsang JLY, Lewis K, Lauzier F, Centofanti J, Rochwerg B, Culgin S, Nelson K, Abdukahil SA, Fiest KM, Stelfox HT, Tlayjeh H, Meade MO, Perri D, Solverson K, Niven DJ, Lim R, Moller MH, Belley-Cote E, Thabane L, Tamim H, Cook DJ, Arabi YM; COVI-PRONE Trial Investigators and the Saudi Critical Care Trials Group. Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2022 Jun 7;327(21):2104-2113. doi: 10.1001/jama.2022.7993.
citation: Alhazzani W, Evans L, Alshamsi F, Moller MH, Ostermann M, Prescott HC, Arabi YM, Loeb M, Ng Gong M, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Machado F, Wunsch H, Crowther M, Cecconi M, Koh Y, Burry L, Chertow DS, Szczeklik W, Belley-Cote E, Greco M, Bala M, Zarychanski R, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Nainan Myatra S, Arrington A, Kleinpell R, Citerio G, Lewis K, Bridges E, Memish ZA, Hammond N, Hayden FG, Alshahrani M, Al Duhailib Z, Martin GS, Kaplan LJ, Coopersmith CM, Antonelli M, Rhodes A. Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update. Crit Care Med. 2021 Mar 1;49(3):e219-e234. doi: 10.1097/CCM.0000000000004899.