NCT06379620CompletedPhase 1
Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive Dysfunction
Pilot Open Label Use of the Hi-OXSR to Increase PaCO2 for the Treatment of Post COVID-19 Cognitive Dysfunction
Source: ClinicalTrials.gov · Last updated 25 Apr 2024
Brief summary (registry, in English)
During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is 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 in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation. Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 22 Apr 2024
- Start date
- 29 Nov 2022
- Primary completion date
- 4 Mar 2024
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06379620
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 37
- From 29 Nov 2022 to the primary completion date, 4 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of cognitive dysfunction prior to COVID infection
- Participating in another investigational trial or the use of an investigational drug within 30 days of screening
Other illness
- Hospitalization for the treatment of COVID
- History of pulmonary hypertension
- History of narcolepsy
- 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
Other
- 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)
- Moderate to severe COPD
- Interstitial Pulmonary Fibrosis
- End-tidal PCO2 \>55 mmHg during training treatment
Who the study is looking for
- Ability to provide written informed consent.
- Previously diagnosed with cognitive dysfunction following recovery from COVID.
- Not pregnant at time of study.
- Oxygen saturation on room air ≥92% at screening.
- Willing and able to comply with the treatment schedule and procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.