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Effect of Hi-OxSR for the Treatment of Post COVID Condition
Sponsor: University Health Network, Toronto
Summary
The RECLAIM study platform will be used to explore whether the use of the Hi-OxSR device improves the symptoms of post covid cognitive dysfunction. Carbon dioxide (CO2) has been proposed as a potential treatment for persistent immune activation as there is evidence that CO2 has antioxidant, anti-inflammatory, and anti-cytokine effects. We conducted a pilot study assessing the open label use of re-breathing CO2 (using Hi-OxSR) twice a day for 14 days, for the treatment of post-COVID cognitive dysfunction. Significant improvements were found in multiple cognitive assessments using TestMyBrain cognitive tests and brain fog (MSNQ) and fatigue scores. This phase 2 clinical trial seeks to build on current findings to determine the optimal effective dose of treatment (i.e. length of use, oxygen concentration, without or without CO2 rebreathing) and the safety of using Hi-OxSR in this patient population.
Official title: RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hi-OxSR for the Treatment of Post COVID Condition (RECLAIM-HiOxSR)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-08-01
Completion Date
2028-12
Last Updated
2025-09-15
Healthy Volunteers
No
Interventions
Hi-OxSR device
The Hi-OxSR device consists of the Hi-Ox mask connected to a portable oxygen concentrator, with added tubing serving as a reservoir for rebreathed exhaled breath.
Hi-Ox device
The Hi-Ox mask is connected to a portable oxygen concentrator.
Locations (3)
Kaye Edmonton Clinic
Edmonton, Alberta, Canada
University Health Network
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada