During the worldwide COVID-19 pandemic a large number patients reported differentfunctional complaints one month or later after recovery from the acute infection. Thisentity had a number of names including "long-COVID" or "post COVID condition". Long-COVIDis on the rise and no effective treatment exists yet to improve cognitive function.Recent research has shown that people with even mild COVID had a greater decline inexecutive function, notably in their ability to perform complex tasks. What drivespost-COVID cognitive changes is still a mystery and there are no effective treatmentsavailable. One hypothesis is that there is persistent immune activation resulting inreduction in cerebral blood flow. There is evidence that increased CO2 may decreaseinflammation, and decreased CO2 may increase inflammation.Objectives: The primary objective of this pilot study is to assess the safety andtolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVIDcognitive dysfunction. The secondary objective is to identify the effects of the use ofthe Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction.
Not Provided
Device: Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)
Subjects will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing
mask (oxygen concentrator), twice a day for 30 minutes with ventilation supplemented by
the subject's rebreathed exhaled air. Total treatment is for 14 days
Inclusion Criteria:
1. Ability to provide written informed consent.
2. Previously diagnosed with cognitive dysfunction following recovery from COVID.
3. Not pregnant at time of study.
4. Oxygen saturation on room air ≥92% at screening.
5. Willing and able to comply with the treatment schedule and procedures.
Exclusion Criteria:
1. History of cognitive dysfunction prior to COVID infection
2. Hospitalization for the treatment of COVID
3. Participating in another investigational trial or the use of an investigational drug
within 30 days of screening
4. For individuals of childbearing potential:
positive pregnancy test at screening or lactating or unwilling to practice a
medically acceptable form of contraception from screening to Day 14 (acceptable
forms of contraception: abstinence, hormonal birth control, intrauterine device, or
barrier method plus a spermicidal agent)
5. History of pulmonary hypertension
6. History of narcolepsy
7. Moderate to severe COPD
8. Interstitial Pulmonary Fibrosis
9. End-tidal PCO2 >55 mmHg during training treatment
10. Presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the subject or the quality of the data
University Health Network
Toronto 6167865, Ontario 6093943, Canada
Angela Cheung, Md, PhD, Principal Investigator
University Health Network, Toronto