RecruitingRecruiting
Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hyperbaric Oxygen Therapy for the Treatment of Post COVID Condition
NCT06452095 · University Health Network, Toronto
In plain English
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Official title
RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hyperbaric Oxygen Therapy for the Treatment of Post COVID Condition (RECLAIM-HBOT)
About this study
This is a Sub-Protocol to the Core Clinical Study Protocol titled: REcovering from COVID19 Lingering symptoms Adaptive Integrative Medicine (RECLAIM),
Eligibility criteria
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. A confirmed ability to travel to one of the three sites where HBOT or sham can be administered.
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. Pneumothorax
7. Poorly controlled seizure disorder
8. Chronic sinusitis
9. Chronic or acute otitis media
10. Major ear drum trauma.
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-01-01
Estimated completion: 2029-12-31
Last updated: 2026-02-23
Interventions
Device: Hyperbaric Oxygen therapy
Primary outcomes
- • Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit (Baseline/Start of intervention to two months)
- • Verbal paired associates [VPA] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit (Baseline/Start of intervention to two months)
Sponsor
University Health Network, Toronto · other
Contacts & investigators
ContactRECLAIM CONTACT RECLAIM contact line · contact · reclaim@uhn.ca · 1-866-673-2524
ContactAndrew Janes, MSc · contact · andrew.janes@uhn.ca
InvestigatorAngela M Cheung, MD, PhD · study_director, University Health Network, Toronto
InvestigatorRita Katznelson, MD · principal_investigator, University Health Network, Toronto
All locations (1)
University Health NetworkRecruiting
Toronto, Ontario, Canada