Portable Oxygen Concentrator (POC) Versus Standard of Care in Long-COVID: Randomized Crossover Exploratory Pilot Study. (RESTORE)

Portable Oxygen Concentrator (POC) Versus Standard of Care in Patients With Long-COVID Cognitive Impairment: a Randomized Crossover Exploratory Pilot Study.

A prospective, open label, randomized, crossover, pilot, exploratory study to describe the effect of the Inogen One® G4 POC on brain hypoxia, peripheral oxygen saturation and cognitive function in adults with longterm- COVID.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Device: Inogen One® G4

Detailed Description

After a 2-week screening/baseline evaluation, participants will be randomized in a 1:1 allocation ratio to one of the following 2 sequences: 1) portable oxygen concentrator (POC) for a first 2-week period followed by standard of care (SOC) for a second 2-week period or 2) SOC for a first 2-week period followed by POC for a second 2-week period. There will be a washout period of one week between the two treatment periods. A total of 10 subjects will be enrolled per sequence.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T1C8
      • Montreal Heart Institute
    • Montréal, Quebec, Canada, H1T1N6
      • Centre ÉPIC de l'Institut de cardiologie de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ability and willingness to give written informed consent prior to any study-specific screening procedures and to comply with the requirements of the study
2. Male or female, aged ≥ 18 years of age
3. Diagnosed with Long-COVID
4. Patient self-reported concerns regarding cognitive functioning or recent diagnosis of COVID-19 related cognitive impairment
5. MoCA test scores ranging from 13 to 25/30 at screening
6. Oxygen saturation SpO2 ≤ 93 % on fingertip pulse oximetry and/or < 60% on brain NIRS, at rest or during effort and/ or 10% relative decrease in brain saturation during exercise as compared to baseline value at screening
7. Ability to perform exercise treadmill test at screening
8. Tolerability of pulsed oxygen (O2) therapy delivered by POC at screening
9. Willingness and ability to wear POC.

Exclusion Criteria:

1. Contraindication to the use of POC including allergy to cannula material
2. Pregnancy or planning to become pregnant during the study
3. Non-COVID-related cause for cognitive impairment (such as Parkinson's disease, multiple sclerosis, Alzheimer's disease, stroke, brain tumor, or dementia)
4. Subjects with respiratory infection at screening or randomization and/or acute bronchitis requiring antibiotics at the time of randomization or expected during the treatment
5. Participation in other interventional clinical trial within 30 days of randomization or expect to participate in any other investigational clinical trial during the conduct of this trial
6. Subjects who should be excluded in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care (SOC); SOC is defined as the patient symptoms or complications based treatment.
Experimental: Portable Oxygen Concentrator; Inogen One® G4 Portable Oxygen Concentrator (POC) is used on a prescriptive basis by subjects requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula which channels oxygen from the concentrator to the subject. Inogen One® G4 is designed to provide a flow of high purity oxygen. Inogen One® G4 may be used in home, institution, vehicle and various mobile environments.	Device: Inogen One® G4; Inogen One® G4 will be used for a minimum of 3h per day at Setting 3 during the intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 related brain hypoxia and peripheral oxygen saturation	To describe the effect of the Inogen One® G4 POC on COVID-19 related brain hypoxia and peripheral oxygen saturation	14+/-3 days
VO2max during cardiopulmonary exercise test	To describe the effect of the Inogen One® G4 POC on VO2max during cardiopulmonary exercise test	14+/-3 days
MoCA test	To describe the effect of the Inogen One® G4 POC on Cognitive performance using the MoCA test	14+/-3 days
Other neuropsychological tests	To describe the effect of the Inogen One® G4 POC on Cognitive health assessments using other neuropsychological tests	14+/-3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	To describe the effect of the Inogen One® G4 POC on post-COVID functional status	14+/-3 days
Anxiety, mood, and subjective cognitive impairment	To describe the effect of the Inogen One® G4 POC on anxiety, mood, and subjective cognitive impairment	14+/-3 days
Pulmonary function	To describe the effect of the Inogen One® G4 POC on the post COVID-19 pulmonary function	14+/-3 days
Safety outcomes	To determine the safety outcomes of the Inogen One® G4 POC in this subject population	14+/-3 days

Collaborators and Investigators

• Sponsor: Inogen Inc.
• Collaborators: The Montreal Health Innovations Coordinating Center (MHICC)

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): March 2, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: INO-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes