Back to resultsAwake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE) (COVI-PRONE)
Primary Purpose
Corona Virus Infection, Covid19, COVID-19
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Awake Proning
Sponsored by
About this trial
This is an interventional treatment trial for Corona Virus Infection
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- University of Texas Health Sciences Centre
- Univeristy of Calgary
- St. Joseph's Healthcare Hamilton
- Hamilton General Hospital
- Juravinski Hospital
- St. Catharine's General -
- Sinai Health System
- University Health Network - Toronto General Hospital
- CHU de Québec - Université Laval
- Al-Amir Hospital
- Jaber Al Ahmed hospital
- King Fahad Hospital of the University
- Prince Mohammed bin Abdulaziz Hospital
- King Abdulaziz Hospital - NGHA
- King Abdulaziz Medical City - Jeddah
- King Abdulaziz Medical City
- King Faisal Specialist Hospital & Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention - Awake Proning
Control - Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Endotracheal intubation
Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.
Secondary Outcome Measures
Mortality
Death
Invasive mechanical ventilation free days
Number of days not receiving mechanical ventilation
Non-invasive ventilation free days
Number of days not receiving non-invasive mechanical ventilation
Days alive and outside ICU
Number of days alive and outside the ICU
Days alive and outside of hospital
Number of days alive and outside of hospital
Complications from proning,
Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other.
Full Information
NCT ID
NCT04350723
First Posted
April 14, 2020
Last Updated
October 14, 2021
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
King Abdullah International Medical Research Center, McMaster University, Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT04350723
Brief Title
Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)
Acronym
COVI-PRONE
Official Title
Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
July 17, 2021 (Actual)
Study Completion Date
July 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
King Abdullah International Medical Research Center, McMaster University, Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection, Covid19, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A multicenter, parallel-group randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention - Awake Proning
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Awake Proning
Intervention Description
The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.
Primary Outcome Measure Information:
Title
Endotracheal intubation
Description
Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.
Time Frame
within 30 days of randomization
Secondary Outcome Measure Information:
Title
Mortality
Description
Death
Time Frame
60 days
Title
Invasive mechanical ventilation free days
Description
Number of days not receiving mechanical ventilation
Time Frame
censored at 30 Days
Title
Non-invasive ventilation free days
Description
Number of days not receiving non-invasive mechanical ventilation
Time Frame
censored 30 days
Title
Days alive and outside ICU
Description
Number of days alive and outside the ICU
Time Frame
60 Days
Title
Days alive and outside of hospital
Description
Number of days alive and outside of hospital
Time Frame
60 days
Title
Complications from proning,
Description
Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed Alhazzani
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yaseen Arabi
Organizational Affiliation
King Saud Bin Abdulaziz University for Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zainab Alduhailib
Organizational Affiliation
King Faisal Specialist Hospital and Research Center, Jeddah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Sciences Centre
City
Dallas
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univeristy of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Catharine's General -
City
St. Catharines
State/Province
Ontario
Country
Canada
Facility Name
Sinai Health System
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
CHU de Québec - Université Laval
City
Quebec
Country
Canada
Facility Name
Al-Amir Hospital
City
Kuwait
Country
Kuwait
Facility Name
Jaber Al Ahmed hospital
City
Kuwait
Country
Kuwait
Facility Name
King Fahad Hospital of the University
City
Khobar
State/Province
Eastern Province
Country
Saudi Arabia
Facility Name
Prince Mohammed bin Abdulaziz Hospital
City
Al Madīnah
Country
Saudi Arabia
Facility Name
King Abdulaziz Hospital - NGHA
City
AlAhsa
Country
Saudi Arabia
Facility Name
King Abdulaziz Medical City - Jeddah
City
Jeddah
Country
Saudi Arabia
Facility Name
King Abdulaziz Medical City
City
Riyadh
Country
Saudi Arabia
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35569448
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.
Results Reference
derived
PubMed Identifier
33555780
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.
Results Reference
derived
Learn more about this trial
Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)
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