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

• ClinicalTrials.gov Identifier: NCT04350723
• Recruitment Status: Completed
• First Posted: April 17, 2020
• Last Update Posted: October 15, 2021
• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: King Abdullah International Medical Research Center; McMaster University; Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): Waleed Al-Hazzani, St. Joseph's Healthcare Hamilton

Tracking Information

• First Submitted Date: April 14, 2020
• First Posted Date: April 17, 2020
• Last Update Posted Date: October 15, 2021
• Actual Study Start Date: June 10, 2020
• Actual Primary Completion Date: July 17, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 14, 2020)

Endotracheal intubation [ Time Frame: within 30 days of randomization ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 21, 2021)

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

Original Secondary Outcome Measures (submitted: April 14, 2020)

• Mortality [ Time Frame: 30 days ]
  Death
• Invasive mechanical ventilation free days [ Time Frame: 30 Days ]
  Number of days not receiving mechanical ventilation
• Non-invasive ventilation free days [ Time Frame: 30 days ]
  Number of days not receiving non-invasive mechanical ventilation
• ICU length of stay [ Time Frame: 30 Days ]
  Number of days admitted to ICU
• Hospital length of stay [ Time Frame: 30 days ]
  Number of days admitted to the hospital
• Change in oxygenation [ Time Frame: 30 days ]
  defined as the difference in SpO2: FiO2 ratio. The difference in SpO2: FiO2 ratio.
• Complications from proning, [ Time Frame: 30 days ]
  Includes any of the following: accidental removal of intravenous access, vomiting, falls from bed, pressure injuries, or cardiac arrest.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A multicenter, parallel-group randomized controlled trial

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Corona Virus Infection
• Covid19
• COVID-19

Intervention

Procedure: Awake Proning

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

Study Arms

• 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.

  Intervention: Procedure: Awake Proning
• 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.

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2021): 400
• Original Estimated Enrollment (submitted: April 14, 2020): 350
• Actual Study Completion Date: July 17, 2021
• Actual Primary Completion Date: July 17, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Kuwait, Saudi Arabia, United States

Administrative Information

• NCT Number: NCT04350723
• Other Study ID Numbers: 2154
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Waleed Al-Hazzani, St. Joseph's Healthcare Hamilton
• Original Responsible Party: Waleed Al-Hazzani, St. Joseph's Healthcare Hamilton, Dr. Waleed Alhazzani
• Current Study Sponsor: St. Joseph's Healthcare Hamilton
• Original Study Sponsor: Same as current

Collaborators

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

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

• PRS Account: St. Joseph's Healthcare Hamilton
• Verification Date: October 2021