AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
The study is an unblinded, randomized, controlled trial for use of the AirFlO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR >20 breaths/min) and/or hypoxia (Oxygen saturation <94% on room air or requiring supplemental oxygen at baseline).

Detailed Description
-----------------
The aim of the study is to determine whether the use of the AirFLO2 device can improve hypoxia as measured by change between partial pressure of arterial oxygen to fraction of inspired oxygen- P:F ratio (PaO2:FiO2) and repeat P:F ratio between 1 to 6 hours after using the device. This is an unblinded, randomized, controlled trial for use of the AirFLO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR >20 breaths/min) and/or hypoxia (Oxygen saturation <94% on room air or requiring supplemental oxygen at baseline). Groups will be analyzed by intention to treat. Per-protocol analyses will also be performed. Descriptive statistics will be reported for the overall subject population, and for the two groups.

Official Title
-----------------
AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19

Conditions
-----------------
Hypoxia, Corona Virus Infection, Respiratory Rate, Covid19

Intervention / Treatment
-----------------
* Device: AirFLO2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥18 years of age with confirmed COVID-19 infection Patient must be able to complete consent and hold mask Baseline room air oxygen saturation <94% or new supplemental oxygen requirement at presentation or patient on supplemental oxygen at baseline and requiring up-titration of oxygen setting Patient in negative pressure room Patient must have access to an internet-connected device Exclusion Criteria: Tracheostomy History of pneumothorax or known bullous lung disease Recent cataract surgery Patient receiving NIV (Noninvasive Ventilation) or HFNC (High Flow Nasal Cannula) Patient receiving mechanical ventilation Delirium

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
Interventional Model Description: Unblinded, randomized, controlled trial with two arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device intervention<br>Intervention participants will receive the AirFLO2 device and training via video with reinforcement from the coordinator how to use and to self-apply it. Clinical data will be recorded before and after intervention. Questionnaires will be completed at baseline and at serial time points after intervention starts. | Device: AirFLO2<br>* Mask device<br>|
| No Intervention: Standard of Care- Control<br>Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | A higher P:F ratio value indicates better oxygenation. Range 20 to 500. | Baseline, 24 hours, 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Dyspnea Symptoms | Improved symptoms related to dyspnea as measured by the change in the Modified Medical Research Council (MMRC).. Range 0 to 4 with lower values being better. | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | 
| Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ) | The Leicester Cough Questionnaire (LCQ) questionnaire has a score range of 3-21, where a higher score indicates better quality of life. | baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients | 
| Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC) | The St George Respiratory Questionnaire (SGRC) questionnaire has a score range of 0-100, where a higher score indicates worse quality of life. | baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients | 
| Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation | Reduce risk of respiratory deterioration as measured by change from baseline to end of hospitalization (discharge or patient death) to high flow nasal cannula (HFNC), non-invasive ventilation (NIV), or invasive ventilation. | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | 
| Number of Participants Transferred to the ICU | Reduced intensive care unit (ICU) transfer risk occurring between baseline and end of hospitalization | baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range) | 
| Number of Participants Requiring Intubation | Reduce risk for intubation requirement as measured by incidence of intubation occurring between baseline and end of hospitalization (discharge or death) | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | 
| Hospitalization Length of Stay in Days | Hospitalization length of stay as measured by length of hospitalization after the baseline timepoint. | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | 
| Number of Participants Who Survived to Discharge | Patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death) | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range) |