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Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518 · Sunnybrook Health Sciences Centre
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Official title
Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments (PCS-HBOT Study)
About this study
Over 500 million individuals worldwide have contracted COVID-19. Among those that have 'recovered' from the acute infection, many suffer from post-COVID-19 condition (experiencing 1 or more symptoms 3 months from the onset of acute COVID-19 infection, with symptoms lasting at least 2 months). Many of these common symptoms, including fatigue, myalgia, and difficulty focusing ('brain fog'), can seriously compromise one's quality of life. Existing treatments predominantly focus on supportive management and specific symptom control, and most approaches have mixed or limited effectiveness. Recently, hyperbaric oxygen therapy (HBOT), acknowledged for its anti-inflammatory effects, has emerged as a potential treatment for post-COVID-19 condition symptoms. However, HBOT is time and resource-intensive, requiring between 20-40 daily treatments. Therefore, the feasibility of assessing HBOT efficacy via a large-scale randomized controlled trial is still being determined. Hence, this study aims to evaluate adherence to the protocol and the feasibility of proceeding with the full trial. The goal of the full trial will be to evaluate the impact of HBOT treatment on post-COVID-19 condition symptoms. This prospective, crossover, randomized pilot trial enrolls adult patients officially diagnosed with post-COVID-19 condition by a healthcare practitioner who continue to experience symptoms, particularly fatigue, at least 3 months following their initial COVID-19 infection. Participants will be assigned randomly (stratified by sex) to either begin HBOT treatments immediately or after a 60-day interval. All patients will be followed for 12 months from the start of treatment, with assessments at the time of enrollment (baseline), start of treatment (if starting 60 days after enrollment), 4 weeks after the start of treatment, and every 2 months from the first HBOT treatment for 1 year. A subjective questionnaire regarding patient satisfaction will also be completed after the last HBOT treatment session and at 1 year after the start of treatment.
Eligibility criteria
Inclusion Criteria: 1. Age ≥ 18 years old 2. Officially diagnosed with post COVID-19 condition by a healthcare practitioner 3. At least three months since SARS-CoV-2 infection 4. Symptoms that persist more than 12 weeks: * Chronic fatigue (must include) along with one of the following symptoms: * Difficulty thinking or problem solving ('brain fog') * Stress or anxiety Exclusion Criteria: 1. Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease) 2. Patients with cognitive difficulties and/or mental retardation before COVID diagnosis 3. History of traumatic brain injury 4. Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town) 5. Known pregnancy or planning a pregnancy in women of childbearing age
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-01-02
Estimated completion: 2027-05
Last updated: 2026-03-16
Interventions
Device: Monoplace Hyperbaric Chamber (Class III medical device).
Primary outcomes
  • Recruitment rate - referral (9 months)
  • Recruitment rate - inclusion (9 months)
  • Recruitment rate - consent (9 months)
Sponsor
Sunnybrook Health Sciences Centre · other
Contacts & investigators
ContactFahad Alam, MD · contact · fahad.alam@sunnybrook.ca · 416-480-4864
ContactLilia Kaustov, PhD · contact · lilia.kaustov@sunnybrook.ca · 416 480-6100
InvestigatorFahad Alam, MD · principal_investigator, Sunnybrook Health Sciences Centre
InvestigatorJordan Tarshis, MD · principal_investigator, Sunnybrook Health Sciences Centre
All locations (1)
Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments · TrialPath