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

COVID-19 Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212831
• Other study ID #: INO-01
• Status: Completed
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: March 2, 2023

Study information

• Verified date: July 2023
• Source: Inogen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Inogen One® G4
Inogen One® G4 will be used for a minimum of 3h per day at Setting 3 during the intervention period.

Locations

Country	Name	City	State
Canada	Centre ÉPIC de l'Institut de cardiologie de Montréal	Montréal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Inogen Inc.	The Montreal Health Innovations Coordinating Center (MHICC)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	VO2max during cardiopulmonary exercise test	To describe the effect of the Inogen One® G4 POC on VO2max during cardiopulmonary exercise test	14+/-3 days
Primary	MoCA test	To describe the effect of the Inogen One® G4 POC on Cognitive performance using the MoCA test	14+/-3 days
Primary	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	Functional status	To describe the effect of the Inogen One® G4 POC on post-COVID functional status	14+/-3 days
Secondary	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
Secondary	Pulmonary function	To describe the effect of the Inogen One® G4 POC on the post COVID-19 pulmonary function	14+/-3 days
Secondary	Safety outcomes	To determine the safety outcomes of the Inogen One® G4 POC in this subject population	14+/-3 days