Corona Virus InfectionAirFLO2NCT04649775
AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
A study testing AirFLO2 in people with Corona Virus Infection and Respiratory Rate, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, Respiratory Rate, Hypoxia
- What is being tested?
- AirFLO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 8 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
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).
Read the 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.
- Conditions
- Corona Virus Infection, Respiratory Rate, Hypoxia, Covid19
- Being tested
- AirFLO2
- Medical subject headings
- Coronavirus Infections, Hypoxia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirFLO2Device
Mask device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AirFLO2 |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation as Measured by P:F Ratio (PaO2:FiO2)
A higher P:F ratio value indicates better oxygenation. Range 20 to 500.
Measured: Baseline, 24 hours, 48 hours
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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)
Measured: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start9 Apr 2021
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Why it stopped: no eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded, randomized, controlled trial with two arms.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- MEDEX
- Responsible party
- Sponsor
- Investigators
- Loretta Que, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649775
- Sponsor's protocol ID
- Pro00105246
- Acronym
- AirFLO2
- Status last verified
- Apr 2022
- First submitted
- 14 Oct 2020
- Last updated
- 25 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04649775
- Acronym / sponsor ID
- AirFLO2 / Pro00105246
- Conditions
- Corona Virus Infection, Respiratory Rate, Hypoxia, Covid19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no eligible participants
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- MEDEX
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Posted 25 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded, randomized, controlled trial with two arms.
| Arm | Type | Receives |
|---|---|---|
| Device intervention | Active comparator | Device: AirFLO2Intervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirFLO2Mask device | Device | Device intervention |
Primary outcome
Oxygenation as Measured by P:F Ratio (PaO2:FiO2)
Time frame: Baseline, 24 hours, 48 hours
A higher P:F ratio value indicates better oxygenation. Range 20 to 500.
8 secondary outcomes
Subject Dyspnea Symptoms
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Number of Participants Transferred to the ICU
Time frame: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)
Number of Participants Requiring Intubation
Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Hospitalization Length of Stay in Days
Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Number of Participants Who Survived to Discharge
Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loretta Que, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirFLO2 in people with Corona Virus Infection and Respiratory Rate, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation as Measured by P:F Ratio (PaO2:FiO2) (time frame: Baseline, 24 hours, 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.