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

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ClinicalTrials.gov Identifier: NCT04649775
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
MEDEX
Information provided by (Responsible Party):
Duke University

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).

Condition or disease Intervention/treatment Phase
Corona Virus Infection Respiratory Rate Hypoxia Covid19 Device: AirFLO2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Unblinded, randomized, controlled trial with two arms.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
Estimated Study Start Date : January 30, 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: AirFLO2
Mask device

No Intervention: Standard of Care- Control
Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.



Primary Outcome Measures :
  1. Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio [ Time Frame: change from baseline compared to one to six hours after initial device intervention ]
    Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio inspired oxygen- P:F ratio (PaO2:FiO2), a higher value indicates better oxygenation. Range 20 to 500.


Secondary Outcome Measures :
  1. Subject dyspnea symptoms [ Time Frame: 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.

  2. Subject cough symptoms [ Time Frame: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients ]
    Improved symptoms related to cough as measured by the change in Leicester Cough Questionnaire (LCQ) questionnaire, score range 3-21, a higher score indicates better quality of life.

  3. Subject respiratory symptoms [ Time Frame: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients ]
    Improve subjective symptoms related to cough as measured by the change in St George Respiratory Questionnaire (SGRC) questionnaire, score range 0-100, a higher score indicates worse quality of life.

  4. Reduced risk progression of respiratory deterioration [ Time Frame: 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

  5. Reduced risk of ICU transfer [ Time Frame: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range) ]
    Reduced intensive care unit (ICU) transfer risk, as measured by a change from baseline to end of hospitalization of ICU admission.

  6. Reduced risk for intubation [ Time Frame: 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)

  7. Reduced hospitalization length of stay [ Time Frame: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range) ]
    Reduced hospitalization length of stay as measured by length of hospitalization after the baseline timepoint.

  8. Increased patient survival to discharge [ Time Frame: baseline to end of hospitalization, (discharge from hospital- 1 - 30 days expected range) ]
    Increased patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649775


Contacts
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Contact: Catherine M Foss, BS (919) 479-0861 DukeAirwayResearch@dm.duke.edu
Contact: Maria A Santoro, MA (919) 479-0861 DukeAirwayResearch@dm.duke.edu

Sponsors and Collaborators
Duke University
MEDEX
Investigators
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Principal Investigator: Loretta Que, MD Duke University Health System
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04649775    
Other Study ID Numbers: Pro00105246
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Tachypnea
Hypoxia
Virus Diseases
Signs and Symptoms, Respiratory
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Respiration Disorders