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

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ClinicalTrials.gov Identifier: NCT04350723
Recruitment Status : Completed
First Posted : April 17, 2020
Last Update Posted : October 15, 2021
Sponsor:
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  ICMJE April 14, 2020
First Posted Date  ICMJE April 17, 2020
Last Update Posted Date October 15, 2021
Actual Study Start Date  ICMJE June 10, 2020
Actual Primary Completion Date July 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A multicenter, parallel-group randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Corona Virus Infection
  • Covid19
  • COVID-19
Intervention  ICMJE 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  ICMJE
  • 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, Evans L, Alshamsi F, Møller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2021)
400
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)
350
Actual Study Completion Date  ICMJE July 17, 2021
Actual Primary Completion Date July 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Kuwait,   Saudi Arabia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04350723
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Waleed Al-Hazzani, St. Joseph's Healthcare Hamilton
Study Sponsor  ICMJE St. Joseph's Healthcare Hamilton
Collaborators  ICMJE
  • King Abdullah International Medical Research Center
  • McMaster University
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP