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RECRUITING
NCT06928506
NA

Effect of Hi-OxSR for the Treatment of Post COVID Condition

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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