Clinical trial NCT05212831: Portable Oxygen Concentrator (POC) Versus Standard of Care in Long-COVID: Randomized Crossover Exploratory Pilot Study.
Official title: Portable Oxygen Concentrator (POC) Versus Standard of Care in Patients With Long-COVID Cognitive Impairment: a Randomized Crossover Exploratory Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Inogen Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Montreal Health Innovations Coordinating Center (MHICC)
First posted: 2022-01-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: COVID-19 related brain hypoxia and peripheral oxygen saturation
timeFrame: 14+/-3 days
measure: VO2max during cardiopulmonary exercise test
timeFrame: 14+/-3 days
measure: MoCA test
timeFrame: 14+/-3 days
measure: Other neuropsychological tests
timeFrame: 14+/-3 days
Secondary outcomes:
measure: Functional status
timeFrame: 14+/-3 days
measure: Anxiety, mood, and subjective cognitive impairment
timeFrame: 14+/-3 days
measure: Pulmonary function
timeFrame: 14+/-3 days
measure: Safety outcomes
timeFrame: 14+/-3 days
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Centre ÉPIC de l'Institut de cardiologie de Montréal
state: Quebec
Study officials:
References: