Hi-OxSR for Post-COVID Syndrome

(RECLAIM-HiOxSR Trial)

Recruiting at 2 trial locations

Overseen By suzanne Cohen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Mechanical ventilation, Organ failure, Pregnancy, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2-4 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device, Hi-OxSR, to determine its effectiveness in improving brain fog and fatigue in individuals with lingering cognitive issues after COVID-19. The device involves re-breathing carbon dioxide (CO2) and may have antioxidant and anti-inflammatory effects. Participants will be divided into groups to test different durations and oxygen levels to identify the best treatment plan. Individuals who have had COVID-19, experience ongoing brain fog or tiredness, and have been symptom-free for at least three months might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for post-COVID cognitive issues.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you must be on standard care therapies for at least 4 weeks before joining the trial.

What prior data suggests that the Hi-OxSR device is safe for treating post-COVID cognitive dysfunction?

A previous study tested the Hi-OxSR device for safety and ease of use. The study focused on individuals with post-COVID cognitive issues, such as brain fog. Participants used the device to inhale carbon dioxide (CO2) for set periods to determine if it could reduce inflammation and improve symptoms.

The results indicated that Hi-OxSR was generally safe. Researchers monitored for any problems, including serious ones, and found no severe or unexpected issues. This suggests that using the device for short periods is likely safe for most people. However, individual reactions may vary, and ongoing research will continue to monitor safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Hi-OxSR for Post-COVID Syndrome because it offers a unique approach compared to standard therapies like rehabilitation or medication for managing lingering symptoms. Hi-OxSR is applied using a low oxygen flow, which is different from traditional high-flow oxygen treatments. This method might enhance recovery by delivering just enough oxygen to stimulate the body’s healing processes without overwhelming it. Additionally, the use of Hi-OxSR twice daily could potentially accelerate improvements in symptoms over a short period, providing a more convenient and accessible option for patients.

What evidence suggests that the Hi-OxSR device is effective for post-COVID cognitive dysfunction?

Studies have shown that the Hi-OxSR device might help with brain fog and tiredness in people who have had COVID-19. In an initial study, patients who used the Hi-OxSR device twice a day for two weeks showed significant improvements in various thinking tests and reported feeling less tired. The device works by rebreathing carbon dioxide (CO2), which might help reduce inflammation and protect cells. These effects could lower the ongoing immune response seen in post-COVID conditions. Early results suggest that Hi-OxSR could be effective in treating post-COVID thinking problems. The ongoing trial will explore different durations and oxygen flow rates to find the best way to use this device for these symptoms. Participants in this trial will be assigned to different groups: some will use Hi-OxSR for two weeks, others for four weeks, and a comparison group will use Hi-Ox at a higher oxygen flow. ^{1 3 5 6 7}

Who Is on the Research Team?

Angela M Cheung, MD, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for people who've had COVID-19 and are experiencing lingering cognitive symptoms for at least 2 months after the initial illness, which occurred 3 months prior to the trial. They must have been treated with standard care for 4 weeks, have an oxygen saturation of ≥92%, and be able to consent and follow study requirements. Women of childbearing age must use approved contraception.

Inclusion Criteria

I tested positive for COVID-19 over 3 months ago or was presumed to have had it after October 15, 2019.

I have had COVID-19 symptoms for more than 3 months since they first appeared.

I have been on standard cancer treatment for at least 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Hi-OxSR device for 30 minutes twice a day at low or high oxygen flow for 2 to 4 weeks

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Hi-OxSR

Trial Overview The RECLAIM study is testing whether using a Hi-OxSR device can improve post-COVID cognitive dysfunction. The device allows patients to re-breathe CO2, which may reduce inflammation and improve brain function. This phase 2 trial aims to find the best dose and safety of this treatment.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 Intervention

Use of Hi-OxSR for 30 minutes twice a day at low oxygen flow (0.5-3 liters per minute) for 4 weeks.

Group II: Group 1 Experimental Treatment 1 Intervention

Use of Hi-OxSR for 30 minutes twice a day at low oxygen flow (0.5-3 liters per minute) for 2 weeks.

Group III: Group 3 Active Control 1 Intervention

Use of Hi-Ox for 30 minutes twice a day at high oxygen flow (5 liters per minute) for 2 weeks.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06379620?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D((AUTOINFLAMMATION,%20ANTIBODY%20DEFICIENCY,%20IMMUNE%20DYSREGULATION)%20OR%20(paco2)))&rank=10

Pilot Open Label Use of the Hi-OXSR for the Treatment ... The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction. Official Title.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10869702/

Long term outcomes of hyperbaric oxygen therapy in post ... The results indicate HBOT can improve the quality of life, quality of sleep, psychiatric and pain symptoms of patients suffering from long COVID.

3. clinicaltrial.be clinicaltrial.be/en/details/536328?per_page=100&condition[0]=PASC%20Post%20Acute%20Sequelae%20of%20COVID%2019&condition[1]=Long%20COVID&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Effect of Hi-OxSR for the Treatment of Post COVID Conditi... Use of Hi-Ox for 30 minutes twice a day at high oxygen flow (5 liters per minute) for 2 weeks. Interventions:Device: Hi-Ox device. Primary ...

4. trial.medpath.com trial.medpath.com/clinical-trial/8f9ff36d214994dc/nct06928506-reclaim-covid-lingering-symptoms-hi-oxsr

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

5. withpower.com withpower.com/trial/phase-post-acute-covid-19-syndrome-3-2025-09741

Hi-OxSR for Post-COVID Syndrome (RECLAIM-HiOxSR Trial) 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.

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0140673

Post-Acute COVID-19 Syndrome (DBCOND0140673) Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome ... Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive ...

7. ctv.veeva.com ctv.veeva.com/study/pilot-open-label-use-of-the-hi-oxsr-for-the-treatment-of-post-covid-cognitive-dysfunction

Pilot Open Label Use of the Hi-OXSR for the Treatment of Post ... Details and patient eligibility · History of cognitive dysfunction prior to COVID infection · Hospitalization for the treatment of COVID.