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

COVID-19 Clinical Trial

— COVI-PRONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350723
• Other study ID #: 2154
• Status: Completed
• Phase: N/A
• Start date: June 10, 2020
• Est. completion date: July 17, 2021

Study information

• Verified date: October 2021
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 17, 2021
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Canada	Univeristy of Calgary	Calgary	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	CHU de Québec - Université Laval	Quebec
Canada	St. Catharine's General -	St. Catharines	Ontario
Canada	Sinai Health System	Toronto	Ontario
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario
Kuwait	Al-Amir Hospital	Kuwait
Kuwait	Jaber Al Ahmed hospital	Kuwait
Saudi Arabia	Prince Mohammed bin Abdulaziz Hospital	Al Madinah
Saudi Arabia	King Abdulaziz Hospital - NGHA	AlAhsa
Saudi Arabia	King Abdulaziz Medical City - Jeddah	Jeddah
Saudi Arabia	King Fahad Hospital of the University	Khobar	Eastern Province
Saudi Arabia	King Abdulaziz Medical City	Riyadh
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh
United States	University of Texas Health Sciences Centre	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Canadian Institutes of Health Research (CIHR), King Abdullah International Medical Research Center, McMaster University

Countries where clinical trial is conducted

United States,  Canada,  Kuwait,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endotracheal intubation	Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.	within 30 days of randomization
Secondary	Mortality	Death	60 days
Secondary	Invasive mechanical ventilation free days	Number of days not receiving mechanical ventilation	censored at 30 Days
Secondary	Non-invasive ventilation free days	Number of days not receiving non-invasive mechanical ventilation	censored 30 days
Secondary	Days alive and outside ICU	Number of days alive and outside the ICU	60 Days
Secondary	Days alive and outside of hospital	Number of days alive and outside of hospital	60 days
Secondary	Complications from proning,	Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other.	30 days

External Links

•   www.COVIPRONE.com