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Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial (COVI-PRONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04350723
Recruitment Status : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
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 Procedure: Awake Proning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 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
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020

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: 30 days ]
    Death

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

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

  4. ICU length of stay [ Time Frame: 30 Days ]
    Number of days admitted to ICU

  5. Hospital length of stay [ Time Frame: 30 days ]
    Number of days admitted to the hospital

  6. Change in oxygenation [ Time Frame: 30 days ]
    defined as the difference in SpO2: FiO2 ratio. The difference in SpO2: FiO2 ratio.

  7. 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.



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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:

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.

Glasgow Coma Scale score <10

Contraindication to proning including any of the following: open chest or abdomen, abdominal surgery (i.e. laparotomy) within the 4 days, or facial, pelvic or cervical spine fractures or instability.

Patient/substitute decision maker (SDM) 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)

Body mass index (BMI) > 40 kg/m2.

Skeletal deformities that interfere with proning such as severe kyphoscoliosis and severe limb contractures.


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


Contacts
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Contact: Sarah Culgin 905-522-1155 ext 32873 sculgin@stjoes.ca
Contact: Zainab Al Duhalib zainajd@gmail.com

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Waleed Alhazzani St. Joseph's Healthcare Hamilton
Additional Information:
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Responsible Party: Waleed Al-Hazzani, Dr. Waleed Alhazzani, 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: April 17, 2020
Last Verified: April 2020
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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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases