Who is eligible for clinical trial NCT06928506?

Participants must meet protocol criteria for Long COVID. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06928506 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-09-11

Effect of Hi-OxSR for the Treatment of Post COVID Condition (NCT06928506)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University Health Network, Toronto

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (14 items).

Location: Kaye Edmonton Clinic — Edmonton, Alberta

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age ≥18 years;
Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019.
Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.
Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms;
Lingering symptoms from COVID-19 present at the time of randomization. "Lingering symptoms of Long COVID" must include self-reported cognitive dysfunction symptoms.
Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. Effective methods of contraception must be discussed and approved by the overseeing Investigator.
Must be able to provide informed consent and both willing and able to comply with study requirements.
Oxygen saturation on room air ≥92% at screening measured by pulse oximeter.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
Contraindications to all of the study interventions;
Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);
Currently pregnant or breastfeeding.
Known physician diagnosis of cognitive dysfunction prior to COVID infection
Use of an investigational drug/device or other interventions within 30 days of screening
Use of home oxygen (O2) at baseline
History of pulmonary hypertension
Interstitial pulmonary fibrosis
Moderate to severe chronic obstructive pulmonary disease (COPD)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Kaye Edmonton Clinic — Edmonton, Alberta
University Health Network — Toronto, Ontario
Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗