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no eligible participants
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| Name | Class |
|---|---|
| MEDEX | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device intervention | Active Comparator | 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. |
|
| Standard of Care- Control | No Intervention | Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirFLO2 | Device | Mask device |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loretta Que, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Standard of Care - Control | Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | A higher P:F ratio value indicates better oxygenation. Range 20 to 500. | Data not collected at 48 hours on two participants in the Standard of Care - Control arm. | Posted | Mean | Standard Deviation | P:F ratio | Baseline, 24 hours, 48 hours |
|
Baseline to end of hospitalization, up to approximately 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Loretta Que, M.D. | Duke University | 919-681-8551 | loretta.que@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2020 | Oct 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000860 | Hypoxia |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Unblinded, randomized, controlled trial with two arms.
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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) |
| BG001 |
| Standard of Care - Control |
Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed. |
|
|
| 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. | Data not collected. | Posted | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) |
|
|
| 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. | Data not collected for one participant in the Standard of Care - Control arm. | Posted | Mean | Standard Deviation | score on a scale | baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients |
|
|
|
| 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. | Data not collected on one participant in the Standard of Care - Control arm. | Posted | Mean | Standard Deviation | score on a scale | baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) |
|
|
|
| Secondary | Number of Participants Transferred to the ICU | Reduced intensive care unit (ICU) transfer risk occurring between baseline and end of hospitalization | Data not collected at 48 hours on two participants in the Standard of Care - Control arm. | Posted | Count of Participants | Participants | baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range) |
|
|
|
| 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) | Posted | Count of Participants | Participants | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) |
|
|
|
| Secondary | Hospitalization Length of Stay in Days | Hospitalization length of stay as measured by length of hospitalization after the baseline timepoint. | Posted | Mean | Full Range | days | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) |
|
|
|
| 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) | Posted | Count of Participants | Participants | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Standard of Care - Control | Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D007239 |
| Infections |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Transfer to ventilation |
|
| 48 hours |
|
|