COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05212831

Not reported

Not reported

2022-01-28

Completed

RCT

Randomized

Crossover

Open label

multi-center

Long covid

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.

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

2

Inogen Inc.

18

100

Canada

Patients recovered from covid

N/A

21

COVID-19 related brain hypoxia and peripheral oxygen saturation;MoCA test;Other neuropsychological tests;VO2max during cardiopulmonary exercise test

None

Not reported

[{"arm_notes": "", "treatment_id": 2135, "treatment_name": "Portable oxygen concentrator", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]