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

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).

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.

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.

Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.

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.

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.

Reduced intensive care unit (ICU) transfer risk occurring between baseline and end of hospitalization

Reduce risk for intubation requirement as measured by incidence of intubation occurring between baseline and end of hospitalization (discharge or death)

Hospitalization length of stay as measured by length of hospitalization after the baseline timepoint.

Patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death)

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