NCT06928506

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

RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hi-OxSR for the Treatment of Post COVID Condition (RECLAIM-HiOxSR)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Sub-Protocol to the Core Clinical Study Protocol titled: REcovering from COVID-19 Lingering symptoms Adaptive Integrative Medicine (RECLAIM)

Conditions

• Long COVID
• Post COVID-19 Condition
• Post Acute Sequelae of COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-04-15
• Last updated: 2025-09-15

Locations

3 sites across 1 country: Canada