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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Covid19; Corona Virus Infection
• Intervention / Treatment: Procedure: Awake Proning

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
    • CHU de Québec - Université Laval
  • Alberta
    • Calgary, Alberta, Canada
      • Univeristy of Calgary
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
    • Hamilton, Ontario, Canada
      • Hamilton General Hospital
    • Hamilton, Ontario, Canada
      • Juravinski Hospital
    • St. Catharines, Ontario, Canada
      • St. Catharine's General -
    • Toronto, Ontario, Canada
      • University Health Network - Toronto General Hospital
    • Toronto, Ontario, Canada
      • Sinai Health System
• Kuwait
  • Kuwait, Kuwait
    • Al-Amir Hospital
  • Kuwait, Kuwait
    • Jaber Al Ahmed hospital
• Saudi Arabia
  • Al Madīnah, Saudi Arabia
    • Prince Mohammed bin Abdulaziz Hospital
  • AlAhsa, Saudi Arabia
    • King Abdulaziz Hospital - NGHA
  • Jeddah, Saudi Arabia
    • King Abdulaziz Medical City - Jeddah
  • Riyadh, Saudi Arabia
    • King Faisal Specialist Hospital & Research Center
  • Riyadh, Saudi Arabia
    • King Abdulaziz Medical City
  • Eastern Province
    • Khobar, Eastern Province, Saudi Arabia
      • King Fahad Hospital of the University
• United States
  • Texas
    • Dallas, Texas, United States, 77030
      • University of Texas Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention - Awake Proning; The oxygen mask or NIPPV or HFNC will be initiated at the treating team's discretion. The patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating oxygen mask or NIPPV or HFNC treatment. Once the patient achieves the above parameters within 15 minutes of initiating oxygen therapy through any modality, the healthcare team will start awake proning.	Procedure: Awake Proning; The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.
NO_INTERVENTION: Control - Standard of Care; The patient will receive usual care without proning at the discretion of the treating team. The oxygen mask or NIPPV or HFNC will be initiated, the choice of starting oxygen mask versus NIPPV versus HFNC will be up to the treating team, the patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating NIPPV or HFNC treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endotracheal intubation	Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.	within 30 days of randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death	60 days
Invasive mechanical ventilation free days	Number of days not receiving mechanical ventilation	censored at 30 Days
Non-invasive ventilation free days	Number of days not receiving non-invasive mechanical ventilation	censored 30 days
Days alive and outside ICU	Number of days alive and outside the ICU	60 Days
Days alive and outside of hospital	Number of days alive and outside of hospital	60 days
Complications from proning,	Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other.	30 days

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: Canadian Institutes of Health Research (CIHR); McMaster University; King Abdullah International Medical Research Center
• Investigators: Principal Investigator: Waleed Alhazzani, St. Joseph's Healthcare Hamilton; Principal Investigator: Yaseen Arabi, King Saud Bin Abdulaziz University for Health Sciences; Principal Investigator: Zainab Alduhailib, King Faisal Specialist Hospital and Research Center, Jeddah

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• www.COVIPRONE.com

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2020
• Primary Completion (ACTUAL): July 17, 2021
• Study Completion (ACTUAL): July 17, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 2154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No