Status:
RECRUITING
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Lead Sponsor:
University Health Network, Toronto
Conditions:
Long COVID
Post COVID-19 Condition
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 potentia...
Detailed Description
This is a Sub-Protocol to the Core Clinical Study Protocol titled: REcovering from COVID-19 Lingering symptoms Adaptive Integrative Medicine (RECLAIM)
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- History of narcolepsy
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06928506
Start Date
August 1 2025
End Date
December 1 2028
Last Update
September 15 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaye Edmonton Clinic
Edmonton, Alberta, Canada
2
University Health Network
Toronto, Ontario, Canada, M5G 2C4
3
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada