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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

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.

Condition or disease Intervention/treatment Phase
Corona Virus Infection Covid19 COVID-19 Procedure: Awake Proning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multicenter, parallel-group randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial
Actual Study Start Date : June 10, 2020
Actual Primary Completion Date : July 17, 2021
Actual Study Completion Date : July 17, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Endotracheal intubation [ Time Frame: within 30 days of randomization ]
    Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 60 days ]
    Death

  2. Invasive mechanical ventilation free days [ Time Frame: censored at 30 Days ]
    Number of days not receiving mechanical ventilation

  3. Non-invasive ventilation free days [ Time Frame: censored 30 days ]
    Number of days not receiving non-invasive mechanical ventilation

  4. Days alive and outside ICU [ Time Frame: 60 Days ]
    Number of days alive and outside the ICU

  5. Days alive and outside of hospital [ Time Frame: 60 days ]
    Number of days alive and outside of hospital

  6. Complications from proning, [ Time Frame: 30 days ]
    Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350723


Locations
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Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
King Abdullah International Medical Research Center
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
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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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Waleed Al-Hazzani, Principal Investigator, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT04350723    
Other Study ID Numbers: 2154
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases