Corona Virus Infection, Covid19, Hypoxia, Respiratory Rate
Conditions
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.
Interventions
DEVICEAirFLO2
Mask device
Sponsors
MEDEX
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Unblinded, randomized, controlled trial with two arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | Baseline, 24 hours, 48 hours | A higher P:F ratio value indicates better oxygenation. Range 20 to 500. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ) | baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients | The Leicester Cough Questionnaire (LCQ) questionnaire has a score range of 3-21, where a higher score indicates better quality of life. |
| Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC) | baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients | The St George Respiratory Questionnaire (SGRC) questionnaire has a score range of 0-100, where a higher score indicates worse quality of life. |
| Number of Participants Transferred 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) | 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. |
| Subject Dyspnea Symptoms | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | 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. |
| Number of Participants Requiring Intubation | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | 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 in Days | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | Hospitalization length of stay as measured by length of hospitalization after the baseline timepoint. |
| Number of Participants Who Survived to Discharge | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range) | Patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death) |
| Number of Participants Transferred to the ICU | baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range) | Reduced intensive care unit (ICU) transfer risk occurring between baseline and end of hospitalization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AirFLO2 Device Intervention 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.
AirFLO2: Mask device | 5 |
| Standard of Care - Control Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed. | 6 |
| Total | 11 |
Baseline characteristics
| Characteristic | AirFLO2 Device Intervention | Total | Standard of Care - Control |
|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 11.8 | 47.6 years STANDARD_DEVIATION 12 | 42.1 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 10 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 2 Participants |
| Region of Enrollment United States | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
Primary
Oxygenation as Measured by P:F Ratio (PaO2:FiO2)
A higher P:F ratio value indicates better oxygenation. Range 20 to 500.
Time frame: Baseline, 24 hours, 48 hours
Population: Data not collected at 48 hours on two participants in the Standard of Care - Control arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AirFLO2 Device Intervention | Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | Baseline | 250.5 P:F ratio | Standard Deviation 35 |
| AirFLO2 Device Intervention | Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | 24 hours | 275.6 P:F ratio | Standard Deviation 61 |
| AirFLO2 Device Intervention | Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | 48 hours | 253.9 P:F ratio | Standard Deviation 64.7 |
| Standard of Care - Control | Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | Baseline | 272.8 P:F ratio | Standard Deviation 44.9 |
| Standard of Care - Control | Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | 24 hours | 264.2 P:F ratio | Standard Deviation 48.8 |
| Standard of Care - Control | Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | 48 hours | 263.0 P:F ratio | Standard Deviation 100.8 |
Secondary
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.
Time frame: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients
Population: Data not collected for one participant in the Standard of Care - Control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AirFLO2 Device Intervention | Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ) | 8.00 score on a scale | Standard Deviation 4.74 |
| Standard of Care - Control | Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ) | 5.60 score on a scale | Standard Deviation 2.79 |
Secondary
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.
Time frame: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients
Population: Data not collected on one participant in the Standard of Care - Control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AirFLO2 Device Intervention | Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC) | -25.33 score on a scale | Standard Deviation 20.61 |
| Standard of Care - Control | Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC) | -23.38 score on a scale | Standard Deviation 24 |
Secondary
Hospitalization Length of Stay in Days
Hospitalization length of stay as measured by length of hospitalization after the baseline timepoint.
Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AirFLO2 Device Intervention | Hospitalization Length of Stay in Days | 6.6 days |
| Standard of Care - Control | Hospitalization Length of Stay in Days | 9.0 days |
Secondary
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)
Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AirFLO2 Device Intervention | Number of Participants Requiring Intubation | 0 Participants |
| Standard of Care - Control | Number of Participants Requiring Intubation | 0 Participants |
Secondary
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.
Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AirFLO2 Device Intervention | Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation | Transfer to HFNC | 2 Participants |
| AirFLO2 Device Intervention | Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation | Transfer to NIV | 0 Participants |
| AirFLO2 Device Intervention | Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation | Transfer to ventilation | 0 Participants |
| Standard of Care - Control | Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation | Transfer to HFNC | 1 Participants |
| Standard of Care - Control | Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation | Transfer to NIV | 0 Participants |
| Standard of Care - Control | Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation | Transfer to ventilation | 0 Participants |
Secondary
Number of Participants Transferred to the ICU
Reduced intensive care unit (ICU) transfer risk occurring between baseline and end of hospitalization
Time frame: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)
Population: Data not collected at 48 hours on two participants in the Standard of Care - Control arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AirFLO2 Device Intervention | Number of Participants Transferred to the ICU | 24 hours | 0 Participants |
| AirFLO2 Device Intervention | Number of Participants Transferred to the ICU | 48 hours | 0 Participants |
| Standard of Care - Control | Number of Participants Transferred to the ICU | 24 hours | 0 Participants |
| Standard of Care - Control | Number of Participants Transferred to the ICU | 48 hours | 1 Participants |
Secondary
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)
Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AirFLO2 Device Intervention | Number of Participants Who Survived to Discharge | 5 Participants |
| Standard of Care - Control | Number of Participants Who Survived to Discharge | 6 Participants |
Secondary
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.
Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Population: Data not collected.