Trial Outcomes & Findings for AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19 (NCT NCT04649775)

NCT ID: NCT04649775

Last Updated: 2022-11-25

Results Overview

A higher P:F ratio value indicates better oxygenation. Range 20 to 500.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Baseline, 24 hours, 48 hours
• Results posted on: 2022-11-25

Participant Flow

Participant milestones

Measure	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	Standard of Care - Control Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
Overall Study STARTED	5	6
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	AirFLO2 Device Intervention n=5 Participants 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	Standard of Care - Control n=6 Participants Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.	Total n=11 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 11.8 • n=5 Participants	42.1 years STANDARD_DEVIATION 9.8 • n=7 Participants	47.6 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 24 hours, 48 hours

Population: Data not collected at 48 hours on two participants in the Standard of Care - Control arm.

A higher P:F ratio value indicates better oxygenation. Range 20 to 500.

Outcome measures

Measure	AirFLO2 Device Intervention n=5 Participants 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	Standard of Care - Control n=6 Participants Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
Oxygenation as Measured by P:F Ratio (PaO2:FiO2) Baseline	250.5 P:F ratio Standard Deviation 35.0	272.8 P:F ratio Standard Deviation 44.9
Oxygenation as Measured by P:F Ratio (PaO2:FiO2) 24 hours	275.6 P:F ratio Standard Deviation 61.0	264.2 P:F ratio Standard Deviation 48.8
Oxygenation as Measured by P:F Ratio (PaO2:FiO2) 48 hours	253.9 P:F ratio Standard Deviation 64.7	263.0 P:F ratio Standard Deviation 100.8

SECONDARY outcome

Timeframe: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)

Population: Data not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

The Leicester Cough Questionnaire (LCQ) questionnaire has a score range of 3-21, where a higher score indicates better quality of life.

Outcome measures

Measure	AirFLO2 Device Intervention n=5 Participants 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	Standard of Care - Control n=5 Participants Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ)	8.00 score on a scale Standard Deviation 4.74	5.60 score on a scale Standard Deviation 2.79

SECONDARY outcome

Timeframe: 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.

The St George Respiratory Questionnaire (SGRC) questionnaire has a score range of 0-100, where a higher score indicates worse quality of life.

Outcome measures

Measure	AirFLO2 Device Intervention n=5 Participants 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	Standard of Care - Control n=5 Participants Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC)	-25.33 score on a scale Standard Deviation 20.61	-23.38 score on a scale Standard Deviation 24.00

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	AirFLO2 Device Intervention n=5 Participants 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	Standard of Care - Control n=6 Participants Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation Transfer to HFNC	2 Participants	1 Participants
Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation Transfer to NIV	0 Participants	0 Participants
Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation Transfer to ventilation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	AirFLO2 Device Intervention n=5 Participants 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	Standard of Care - Control n=6 Participants Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
Number of Participants Transferred to the ICU 24 hours	0 Participants	0 Participants
Number of Participants Transferred to the ICU 48 hours	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	AirFLO2 Device Intervention n=5 Participants 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	Standard of Care - Control n=6 Participants Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
Number of Participants Requiring Intubation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	AirFLO2 Device Intervention n=5 Participants 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	Standard of Care - Control n=6 Participants Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
Hospitalization Length of Stay in Days	6.6 days Interval 4.0 to 8.0	9.0 days Interval 3.0 to 32.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	AirFLO2 Device Intervention n=5 Participants 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	Standard of Care - Control n=6 Participants Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
Number of Participants Who Survived to Discharge	5 Participants	6 Participants

Adverse Events

AirFLO2 Device Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care - Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Loretta Que, M.D.

Duke University

Phone: 919-681-8551

Email: loretta.que@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place