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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Device: Inogen One® G4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability and willingness to give written informed consent prior to any study-specific screening procedures and to comply with the requirements of the study Male or female, aged ≥ 18 years of age Diagnosed with Long-COVID Patient self-reported concerns regarding cognitive functioning or recent diagnosis of COVID-19 related cognitive impairment MoCA test scores ranging from 13 to 25/30 at screening 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 Ability to perform exercise treadmill test at screening Tolerability of pulsed oxygen (O2) therapy delivered by POC at screening Willingness and ability to wear POC. Exclusion Criteria: Contraindication to the use of POC including allergy to cannula material Pregnancy or planning to become pregnant during the study Non-COVID-related cause for cognitive impairment (such as Parkinson's disease, multiple sclerosis, Alzheimer's disease, stroke, brain tumor, or dementia) Subjects with respiratory infection at screening or randomization and/or acute bronchitis requiring antibiotics at the time of randomization or expected during the treatment 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 Subjects who should be excluded in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care (SOC)<br>SOC is defined as the patient symptoms or complications based treatment. | |
| Experimental: Portable Oxygen Concentrator<br>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<br>* Inogen One® G4 will be used for a minimum of 3h per day at Setting 3 during the intervention period.<br>|

What is the study measuring?
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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 |