The RECLAIM study platform will be used to explore whether the use of the Hi-OxSR deviceimproves the symptoms of post covid cognitive dysfunction. Carbon dioxide (CO2) has beenproposed as a potential treatment for persistent immune activation as there is evidencethat CO2 has antioxidant, anti-inflammatory, and anti-cytokine effects. We conducted apilot study assessing the open label use of re-breathing CO2 (using Hi-OxSR) twice a dayfor 14 days, for the treatment of post-COVID cognitive dysfunction. Significantimprovements were found in multiple cognitive assessments using TestMyBrain cognitivetests and brain fog (MSNQ) and fatigue scores. This phase 2 clinical trial seeks to buildon current findings to determine the optimal effective dose of treatment (i.e. length ofuse, oxygen concentration, without or without CO2 rebreathing) and the safety of usingHi-OxSR in this patient population.
This is a Sub-Protocol to the Core Clinical Study Protocol titled: REcovering from
COVID-19 Lingering symptoms Adaptive Integrative Medicine (RECLAIM)
Device: Hi-OxSR device
The Hi-OxSR device consists of the Hi-Ox mask connected to a portable oxygen
concentrator, with added tubing serving as a reservoir for rebreathed exhaled breath.
Device: Hi-Ox device
The Hi-Ox mask is connected to a portable oxygen concentrator.
Inclusion Criteria:
1. Age ≥18 years;
2. 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.
3. 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.
4. 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;
5. Lingering symptoms from COVID-19 present at the time of randomization. "Lingering
symptoms of Long COVID" must include self-reported cognitive dysfunction symptoms.
6. 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.
7. Must be able to provide informed consent and both willing and able to comply with
study requirements.
8. Oxygen saturation on room air ≥92% at screening measured by pulse oximeter.
Exclusion Criteria:
1. Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for
COVID-19;
2. Current end-organ failure, organ transplantation, or current hospitalization in
acute care hospital;
3. Contraindications to all of the study interventions;
4. Co-enrolment in another interventional trial (co-enrolment in an observational study
is permitted);
5. Currently pregnant or breastfeeding.
6. Known physician diagnosis of cognitive dysfunction prior to COVID infection
7. Use of an investigational drug/device or other interventions within 30 days of
screening
8. Use of home oxygen (O2) at baseline
9. History of pulmonary hypertension
10. Interstitial pulmonary fibrosis
11. Moderate to severe chronic obstructive pulmonary disease (COPD)
12. History of narcolepsy
13. 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.
Not Provided
suzanne Cohen
1-866-673-2524
reclaim@uhn.ca
Angela M Cheung, MD, PhD, Principal Investigator
University Health Network, Toronto