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

NCT ID: NCT05212831

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2023-03-02

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care (SOC)

SOC is defined as the patient symptoms or complications based treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Inogen One® G4

Intervention Type: DEVICE

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

Interventions

Inogen One® G4

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Montreal Health Innovations Coordinating Center (MHICC)

OTHER

Sponsor Role: collaborator

Inogen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Montreal Heart Institute

Montreal, Quebec, Canada

Centre ÉPIC de l'Institut de cardiologie de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

INO-01

Identifier Type: -

Identifier Source: org_study_id