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

NCT04350723 | Completed DMC

• 1 other identifier: 2154
• Study Type: interventional
• Target: 400
• Locations: 4 countries
• Sites: 17

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.

Conditions

Corona Virus Infection; COVID-19

Outcome Measures

Primary Outcomes (1)

• Endotracheal intubation

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

  within 30 days of randomization

Secondary Outcomes (6)

• Mortality

  60 days

• Invasive mechanical ventilation free days

  censored at 30 Days

• Non-invasive ventilation free days

  censored 30 days

• Days alive and outside ICU

  60 Days

• Days alive and outside of hospital

  60 days

Study Arms (2)

Intervention - Awake Proning

EXPERIMENTAL

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

Control - Standard of Care

NO INTERVENTION

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.

Interventions

Awake Proning PROCEDURE

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

Intervention - Awake Proning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• King Abdullah International Medical Research Center: collaborator
• McMaster University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (17)

University of Texas Health Sciences Centre

Dallas, Texas, 77030, United States

Location

Univeristy of Calgary

Calgary, Alberta, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

St. Catharine's General -

St. Catharines, Ontario, Canada

Location

Sinai Health System

Toronto, Ontario, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Location

CHU de Québec - Université Laval

Québec, Canada

Location

Al-Amir Hospital

Kuwait City, Kuwait

Location

Jaber Al Ahmed hospital

Kuwait City, Kuwait

Location

King Fahad Hospital of the University

Khobar, Eastern Province, Saudi Arabia

Location

Prince Mohammed bin Abdulaziz Hospital

Al Madīnah, Saudi Arabia

Location

King Abdulaziz Hospital - NGHA

AlAhsa, Saudi Arabia

Location

King Abdulaziz Medical City - Jeddah

Jeddah, Saudi Arabia

Location

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

Location

Related Publications (2)

• 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.

  PMID: 35569448 DERIVED

• 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.

  PMID: 33555780 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A multicenter, parallel-group randomized controlled trial

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: June 10, 2020
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (6); CA (8); KU (2); US (1)