Actively Recruiting
Effect of Hi-OxSR and Hi-Ox Devices for Treating Post COVID Condition in the RECLAIM Trial
Led by University Health Network, Toronto · Updated on 2025-09-15
120
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether using the Hi-OxSR device can improve symptoms of post COVID cognitive dysfunction. This condition involves lingering cognitive problems following COVID-19 infection, sometimes called "brain fog." Carbon dioxide (CO2) has been suggested as a possible treatment because it may reduce inflammation and immune activation. A previous pilot study showed that using this device twice daily for 14 days improved cognitive tests and reduced fatigue and brain fog. This phase 2 trial aims to find the best treatment dose and assess the safety of the Hi-OxSR device for people with post COVID symptoms. Participants will be randomly assigned to one of three groups. One group uses the Hi-OxSR device for 30 minutes twice a day at a low oxygen flow rate (0.5-3 liters per minute) for 2 weeks. Another group uses the same device and schedule for 4 weeks. The third group uses the Hi-Ox device (without CO2 rebreathing) for 30 minutes twice a day at a higher oxygen flow rate (5 liters per minute) for 2 weeks. The devices consist of a mask connected to a portable oxygen concentrator, with the Hi-OxSR adding a reservoir tube for rebreathed breath. During the study, participants will complete online cognitive tests and questionnaires about brain fog, fatigue, mental health, breathing difficulties, and symptoms at various times up to six months. Blood samples will be collected at the start and after 2 months. Safety and adverse events will be monitored throughout. The main outcomes measured include reaction time and verbal memory from baseline to two months. Participants are expected to follow the treatment schedule and attend assessments over the study period lasting up to six months.
CONDITIONS
Brief 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 PCR, antibody, or antigen at least 3 months before randomization, or presumed COVID-19 diagnosed by investigator after October 15, 2019
- Treated with standard care therapies for at least 4 weeks before joining
- Lingering COVID-19 symptoms lasting at least 2 months beyond 3 months from acute infection onset
- Lingering symptoms present at randomization including self-reported cognitive dysfunction
- Female participants of childbearing potential must agree to abstinence or effective contraception during study
- Able to provide informed consent and comply with study requirements
- Oxygen saturation on room air 92% or higher at screening measured by pulse oximeter
You will not qualify if you...
- Previous mechanical ventilation or ECMO for COVID-19
- Current end-organ failure, organ transplant, or acute hospital admission
- Contraindications to all study interventions
- Co-enrolled in another interventional trial
- Currently pregnant or breastfeeding
- Known diagnosis of cognitive dysfunction before COVID infection
- Use of investigational drugs or devices within 30 days before screening
- Use of home oxygen at baseline
- History of pulmonary hypertension
- Interstitial pulmonary fibrosis
- Moderate to severe chronic obstructive pulmonary disease
- History of narcolepsy
- Any condition deemed by investigator to compromise safety or data quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 weeks
Participants use the Hi-OxSR or Hi-Ox device for 30 minutes twice a day at specified oxygen flow rates depending on their assigned group.
Daily use for up to 4 weeks with periodic visits during treatment
Duration - Up to 6 months
Participants are monitored for cognitive performance, symptoms, safety, and quality of life after treatment.
Visits at 2 weeks, 1 month, 2 months, and 6 months after starting treatment
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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