Actively Recruiting
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Led by University Health Network, Toronto · Updated on 2025-09-15
120
Participants Needed
3
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Positive COVID-19 test by nasopharyngeal swab RT-PCR, antibody, or antigen test at least 3 months before randomization, OR presumed COVID-19 diagnosed by investigator after October 15, 2019
- Have been treated with standard care therapies for at least 4 weeks before entering the trial
- Lingering COVID-19 symptoms lasting at least 2 months beyond 3 months from onset of acute COVID
- Lingering symptoms at randomization include self-reported cognitive dysfunction
- Female patients of childbearing potential who are sexually active agree to abstinence or effective contraception during study
- Able to provide informed consent and willing to comply with study requirements
- Oxygen saturation on room air 92% or higher at screening measured by pulse oximeter
You will not qualify if you...
- Mechanical ventilation or extracorporeal membrane oxygen (ECMO) treatment for COVID-19
- Current end-organ failure, organ transplant, or hospitalization in acute care
- Contraindications to all study interventions
- Participation in another interventional trial (observational study allowed)
- Currently pregnant or breastfeeding
- Physician diagnosis of cognitive dysfunction before COVID infection
- Use of investigational drug/device or other interventions within 30 days of screening
- Use of home oxygen at baseline
- History of pulmonary hypertension
- Interstitial pulmonary fibrosis
- Moderate to severe chronic obstructive pulmonary disease (COPD)
- History of narcolepsy
- Any condition that investigator believes compromises safety or data quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Kaye Edmonton Clinic
Edmonton, Alberta, Canada
Not Yet Recruiting
2
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
3
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Not Yet Recruiting
Research Team
S
suzanne Cohen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here