COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss

Study Overview
=================
Brief Summary
-----------------
Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.

Official Title
-----------------
Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19

Conditions
-----------------
Coronavirus Infection, COVID, Severe Acute Respiratory Syndrome, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome, ARDS, Lung Diseases

Intervention / Treatment
-----------------
* Procedure: Awake Prone Positioning
* Procedure: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19, either confirmed by SARS-CoV-2 assay, or clinically suspected, with results of the assay pending; Lung infiltrates documented on chest X-ray or chest CT-scan; Significant respiratory distress that requires treatment with HFNO. Exclusion Criteria: Unable to consent; Unable to prone; Indication for immediate endotracheal intubation and mechanical ventilation; Contraindication to prone positioning (severe obesity, abdominal wound, pregnancy, unstable pelvic/spinal lesions, vomiting, etc.); Comfort care or imminent expectation of death.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Awake prone positioning<br>Prone positioning of patients on nasal high-flow oxygen therapy | Procedure: Awake Prone Positioning<br>* Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h<br>|
| Active Comparator: Standard care<br>Standard decubitus positioning of patients on nasal high-flow oxygen therapy | Procedure: Standard care<br>* Patients will not receive any special instructions with regards to proning.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death |  | Up to 28 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate |  | Up to 28 days after randomization | 
| Mortality |  | Up to 28 days after randomization | 
| Days spent on mechanical ventilation |  | Until discharge, up to 24 weeks after randomization | 
| Days spent in the ICU |  | Until discharge, up to 24 weeks after randomization | 
| Hospital stay (in days) |  | From admission to discharge, up to 24 weeks after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, SARS-CoV-2 infection, COVID-19, HFNC, HFNO, Proning, Prone position, High-flow nasal cannula, High-flow nasal oxygenation, Acute Respiratory Distress Syndrome