Hyperbaric Oxygen Therapy for Long COVID

(PCS-HBOT Trial)

Overseen By Lilia Kaustov, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Pneumothorax, Traumatic brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy for Long COVID?

Research suggests that Hyperbaric Oxygen Therapy (HBOT) can improve symptoms of Long COVID, such as fatigue and cognitive impairment, by enhancing oxygen delivery and reducing inflammation. Studies have shown significant improvements in physical and emotional well-being, energy levels, and social functioning in patients after undergoing HBOT sessions. ^{1 2 3 4 5}

How does hyperbaric oxygen therapy differ from other treatments for long COVID?

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing 100% oxygen in a pressurized chamber, which enhances oxygen delivery to the bloodstream and can improve microcirculation, reduce inflammation, and promote neurological repair. Unlike other treatments, HBOT specifically targets these mechanisms, offering a novel approach to improving symptoms and quality of life for long COVID patients. ^{1 2 3 5 6}

Research Team

Jordan Tarshis, MD,FRCPC

Principal Investigator

Sunnybrook Health Sciences Centre

Fahad Alam, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

Adults diagnosed with post COVID-19 condition, experiencing chronic fatigue and at least one other symptom like 'brain fog' or anxiety for over 12 weeks since infection. Excludes those with traumatic brain injury, unstable living situations, pregnant women or those planning pregnancy, pre-existing cognitive issues, and anyone unfit for hyperbaric treatments.

Inclusion Criteria

It has been over 3 months since I recovered from COVID-19.

I have had chronic fatigue and either brain fog, stress, or anxiety for more than 12 weeks.

I am 18 years old or older.

Exclusion Criteria

I am medically fit for hyperbaric treatments and do not have conditions like pneumothorax or unstable heart disease.

Known pregnancy or planning a pregnancy in women of childbearing age

Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hyperbaric oxygen therapy (HBOT) treatments, starting immediately or after a 60-day interval, with a minimum of 4 treatments per week and more than 35 treatments in total

8 weeks

Daily visits for HBOT sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments every 2 months for 1 year

12 months

Assessments at 4 weeks after treatment start and every 2 months

Long-term follow-up

Participants complete a subjective questionnaire regarding patient satisfaction and long-term symptomatic impact at 1 year

12 months

Treatment Details

Interventions

• Hyperbaric Oxygen Therapy

Trial Overview The trial is testing hyperbaric oxygen therapy—a treatment where patients breathe high levels of oxygen in a special chamber—to see if it can alleviate symptoms of post COVID-19 condition such as persistent fatigue and 'brain fog'.

Participant Groups

Group I: Immediate start of hyperbaric treatments Experimental Treatment 1 Intervention

HBOT treatments will be scheduled to start immediately after referral.

Group II: Delayed start of hyperbaric treatments Experimental Treatment 1 Intervention

HBOT treatments will be scheduled to start 60 days after referral.

Hyperbaric Oxygen Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury

Approved in European Union as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury
• Diabetic foot ulcers

Approved in Canada as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury

Approved in Japan as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Findings from Research

In a pilot study involving 50 patients with moderate to severe ARDS due to COVID-19, hyperbaric oxygen therapy (HBOT) significantly improved oxygen saturation levels, with all participants achieving a PaO2 of 90 mmHg after three sessions.

HBOT effectively reduced the need for additional oxygen supplementation, indicating its potential as a beneficial adjuvant therapy for managing respiratory failure in COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Outcome of HBOT as an Adjuvant Therapy in Patients Diagnosed with COVID-19 in a Tertiary Care Hospital - A Preliminary Study. Palaniappan, T., Shaikh, A., Kirthika, N.[2022]

In a study involving 10 patients with long COVID, hyperbaric oxygen therapy (HBOT) significantly improved fatigue and cognitive functions after 10 treatment sessions, indicating its potential as an effective intervention.

Statistical analysis showed very large effect sizes in fatigue reduction and substantial improvements in cognitive areas such as attention and executive function, suggesting that HBOT could be a promising treatment for debilitating long COVID symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for the treatment of long COVID: early evaluation of a highly promising intervention. Robbins, T., Gonevski, M., Clark, C., et al.[2023]

In a study of 70 patients with Long COVID syndrome, hyperbaric oxygenation (HBO) treatment showed significant improvements in various health aspects, including physical functioning and emotional well-being, after 10 sessions.

The results indicate that HBO could be a promising supportive therapy for Long COVID, with improvements sustained even three months after treatment, highlighting its potential efficacy in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate and Long-Term Effects of Hyperbaric Oxygenation in Patients with Long COVID-19 Syndrome Using SF-36 Survey and VAS Score: A Clinical Pilot Study. Lindenmann, J., Porubsky, C., Okresa, L., et al.[2023]

In a study of 36 hospitalized COVID-19 patients with hypoxia, those who received hyperbaric oxygen (HBO2) therapy had a significantly lower mortality rate (13%) compared to those who did not receive treatment (50%), suggesting potential therapeutic benefits of HBO2.

However, after adjusting for factors like age and baseline hypoxia, the difference in mortality rates was not statistically significant, indicating that while HBO2 may show promise, further research is needed to confirm its efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen for COVID-19 patients with severe hypoxia prior to vaccine availability. Jansen, D., Dickstein, DR., Erazo, K., et al.[2022]

Long COVID symptoms, which can include fatigue, dyspnea, and cognitive impairment, typically arise within 3 months of a COVID-19 infection and can last for over 2 months, with various proposed mechanisms behind their persistence.

Hyperbaric oxygen therapy (HBOT) has shown promise in clinical trials for treating long COVID, as it may improve symptom severity, reduce duration, and enhance quality of life for patients, making it a potentially effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen Treatment for Long COVID: From Molecular Mechanism to Clinical Practice. Pan, JQ., Tian, ZM., Xue, LB.[2023]

This randomized, placebo-controlled trial will assess the efficacy of hyperbaric oxygen therapy (HBOT) in improving health-related quality of life (HRQoL) in 80 patients suffering from long COVID-19, with evaluations occurring over 52 weeks.

The study aims to determine if HBOT can enhance not only HRQoL but also endothelial function and physical performance, addressing a significant gap in effective treatments for long COVID-19 symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial. Kjellberg, A., Abdel-Halim, L., Hassler, A., et al.[2022]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Effective Outcome of HBOT as an Adjuvant Therapy in Patients Diagnosed with COVID-19 in a Tertiary Care Hospital - A Preliminary Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for the treatment of long COVID: early evaluation of a highly promising intervention. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Immediate and Long-Term Effects of Hyperbaric Oxygenation in Patients with Long COVID-19 Syndrome Using SF-36 Survey and VAS Score: A Clinical Pilot Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen for COVID-19 patients with severe hypoxia prior to vaccine availability. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen Treatment for Long COVID: From Molecular Mechanism to Clinical Practice. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial. [2022]