NCT06082518

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments (PCS-HBOT Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Over 500 million people have been infected with COVID-19, and to date, more than 6 million people have died. Many individuals who have recovered from COVID-19 continue to experience symptoms even after they have been "cured" of the disease. This condition is known as post COVID-19 condition, which can have serious health consequences. A common symptom among these individuals is chronic fatigue, characterized by persistent tiredness or lack of energy. This study aims to explore a novel treatment for symptoms of post COVID-19 condition, known as hyperbaric oxygen therapy. This approach has shown promise in helping people with post COVID-19 conditions and treating some other causes of fatigue. Hyperbaric oxygen therapy involves placing patients in a small chamber where they receive high oxygen gas levels. However, this treatment is expensive and time-consuming, and it is unclear if this treatment can be effectively assessed in a large-scale research study. This small study will help us decide if conducting a large research study is feasible. The investigators aim to assess if hyperbaric oxygen therapy can improve symptoms of post COVID-19 condition, such as fatigue.

Detailed description

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.

Conditions

• Post COVID-19 Condition
• Post-COVID-19 Syndrome
• Post-COVID Syndrome
• COVID-19
• Fatigue
• Fatigue Syndrome, Chronic

Interventions

Type	Name	Description
DEVICE	Monoplace Hyperbaric Chamber (Class III medical device).	40 hyperbaric oxygen therapy (HBOT) treatments (90 minute exposures at 2 atmospheres (ATM) per treatment), scheduled daily from Monday to Friday (i.e., 5 treatments per week) until treatments are completed (approximately 8 weeks). Treatments will be delivered in a medical grade, Health Canada-approved monoplace hyperbaric chamber and overseen by specialist hyperbaric physicians and a Certified Hyperbaric Technologist. Device is being used in manner consistent with approved usage in Canada.

Timeline

• Start date: 2024-01-02
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2023-10-13
• Last updated: 2026-03-16

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study