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

NCT04649775 | Terminated Results FDA Device

• 1 other identifier: Pro00105246
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Corona Virus Infection; Respiratory Rate; Hypoxia; Covid19

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Subject Dyspnea Symptoms

  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)

  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)

  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

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

• Number of Participants Transferred to the ICU

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

Study Arms (2)

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.

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.

Interventions

AirFLO2 DEVICE

Mask device

Device intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• MEDEX: collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Hypoxia; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Loretta Que, M.D.
• Organization: Duke University

loretta.que@duke.edu

919-681-8551

Study Officials

• Loretta Que, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unblinded, randomized, controlled trial with two arms.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: December 2, 2020
• Study Start: April 9, 2021
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: November 25, 2022
• Results First Posted: November 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)