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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests hyperbaric oxygen therapy (HBOT) as a potential treatment for ongoing symptoms after recovering from COVID-19, often called long COVID. The focus is on alleviating chronic fatigue, a common issue for those affected. Participants will either begin this therapy immediately or after a short delay. Suitable candidates include individuals diagnosed with long COVID who experience fatigue and may also have difficulty thinking clearly or feel stressed. As an unphased trial, this study provides a unique opportunity to explore a promising treatment option for long COVID symptoms.

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 prior data suggests that hyperbaric oxygen therapy is safe for treating post COVID-19 condition?

Research has shown that hyperbaric oxygen therapy (HBOT) is generally well-tolerated for treating post-COVID-19 conditions, such as chronic fatigue. Several studies have found HBOT safe for individuals with long COVID, with no reports of symptoms worsening after treatment.

Most participants in these studies did not experience serious side effects. Some mild side effects, like ear discomfort or sinus pressure, can occur, similar to sensations during a plane takeoff or landing. Overall, the safety data suggests that HBOT is a promising option for those suffering from long-term COVID-19 symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperbaric oxygen therapy (HBOT) for Long COVID because it offers a unique approach compared to standard treatments like symptom management through medications or rehabilitation exercises. Unlike these traditional methods, HBOT involves breathing pure oxygen in a pressurized chamber, which can potentially enhance oxygen delivery to damaged tissues and promote healing. This method addresses the condition at a cellular level, which is different from just alleviating symptoms. By potentially improving cellular repair and reducing inflammation, HBOT could offer a more comprehensive recovery option for Long COVID sufferers.

What evidence suggests that hyperbaric oxygen therapy might be an effective treatment for post COVID-19 condition?

Research shows that hyperbaric oxygen therapy (HBOT) might help people with long COVID. In this trial, participants will join one of two groups: one group will start HBOT treatments immediately after referral, while the other will begin treatments 60 days later. Studies have found that HBOT can improve symptoms like tiredness, thinking problems, and overall quality of life. One study also noted better sleep and fewer psychological issues. The therapy involves breathing in high levels of oxygen in a special chamber, which may help the body heal. Early evidence suggests that HBOT is safe and can provide lasting benefits for those dealing with post-COVID conditions. ^{2 3 5 6 7}

Who Is on the Research Team?

Fahad Alam, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Jordan Tarshis, MD,FRCPC

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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 have been officially diagnosed with long COVID.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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'.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11051078/

Effects of Hyperbaric Oxygen Therapy on Long COVID The authors emphasized that HBOT promotes the recovery of left ventricular systolic function in patients suffering from long COVID. 4.

2. nature.com nature.com/articles/s41598-025-11539-0

Hyperbaric oxygen therapy for long COVID: a prospective ... A sham-controlled, randomized trial showed significant improvements in cognitive symptoms, quality of life, sleep, psychological symptoms and ...

3. esmed.org esmed.org/hyperbaric-oxygen-therapy-for-long-covid-evidence-review/

Hyperbaric Oxygen Therapy for Long COVID: Evidence ... The results are uniformly positive, the treatment is safe, and the results are long lasting. Affordable access and availability of HBO ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04358926

Hyperbaric Oxygen Therapy Effect in COVID-19 RCT ... Recent case series reported the use of Hyperbaric Oxygen Therapy (HBOT) on 5 severe COVID-19 patients who developed respiratory insufficiency. HBOT mechanisms ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8608448/

Efficacy and safety of hyperbaric oxygen treatment in SARS ... HBOT is safe and may be a promising intervention to optimise treatment and outcomes in hypoxaemic COVID-19 patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11138265/

Efficacy and safety of hyperbaric oxygen therapy for long ... Several studies have shown the benefit of hyperbaric oxygen therapy (HBOT) on long COVID. However, the efficacy and safety of HBOT for long COVID remain ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04647656

Hyperbaric Oxygen Therapy for Post-COVID-19 Syndrome The protocol includes 40 daily sessions, 5 sessions per week for two months. Treatment group will subjected to 100% oxygen by mask at 2 atmosphere (ATA) for 90 ...