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NCT Number: NCT06082518

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location status: Recruiting

Location contact

Adrienne Chan, MD

SUB_INVESTIGATOR

Fahad Alam, MD

CONTACT

[email protected]

416-480-4864

Jordan Tarshis, MD,FRCPC

PRINCIPAL_INVESTIGATOR

Oskar Singer, MD,FRCPC

SUB_INVESTIGATOR

Peter Giacobbe, MD

SUB_INVESTIGATOR

Stanley Hamstra, PhD

SUB_INVESTIGATOR

Stephen Choi, MD,FRCPC

SUB_INVESTIGATOR

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Officially diagnosed with post COVID-19 condition by a healthcare practitioner
  • At least three months since SARS-CoV-2 infection
  • 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

  • Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease)
  • Patients with cognitive difficulties and/or mental retardation before COVID diagnosis
  • History of traumatic brain injury
  • Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)
  • Known pregnancy or planning a pregnancy in women of childbearing age

Treatment and study plan

Monoplace Hyperbaric Chamber (Class III medical device).

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.

Primary outcomes

  1. Recruitment rate - referral

    Time frame: 9 months

    Quantify referral rate from healthcare providers

  2. Recruitment rate - inclusion

    Time frame: 9 months

    Number of patients meeting inclusion criteria

  3. Recruitment rate - consent

    Time frame: 9 months

    Patient consent rate

  4. Adherence to HBOT protocol

    Time frame: 9 months recruitment + 8 weeks treatment

    Number of Participants received minimum 4 treatments per week with >35 treatments

  5. Adherence to HBOT protocol - satisfaction

    Time frame: After last HBOT treatment and at 12 month follow-up

    Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment

  6. Feasibility of Clinical Outcome Measures

    Time frame: Up to 1 year after start of treatment

    Feasibility of implementation of clinical outcome scales (PDQ, FSS, SF-36) to be completed 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.

Secondary outcomes

  1. The impact of HBOT on post COVID-19 condition - PDQ

    Time frame: Up to 1 year after start of treatment

    The validated clinical deficit scale, Perceived Deficits Questionnaire (PDQ), will be used 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

  2. The impact of HBOT on post COVID-19 condition - FSS

    Time frame: Up to 1 year after start of treatment

    The validated clinical deficit scale, Fatigue Severity Scale (FSS), will be used 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

  3. The impact of HBOT on post COVID-19 condition - SF-36

    Time frame: Up to 1 year after start of treatment

    The validated clinical deficit scale, QoL Short Form Survey (SF-36), will be used 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.

  4. The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ

    Time frame: Up to 1 year after start of treatment

    Validated clinical deficit scales PDQ will be compared with FSS and SF-36 between immediate and delayed start groups

  5. The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS

    Time frame: Up to 1 year after start of treatment

    Validated clinical deficit scale FSS will be compared with PDQ and SF-36 between immediate and delayed start groups

  6. The impact of time to initiation of HBOT on outcomes following initial infection outcome - SF-36

    Time frame: Up to 1 year after start of treatment

    Validated clinical deficit scale SF-36 will be compared with PDQ and FSS between immediate and delayed start groups

  7. Initial infection severity as a mediator of HBOT impact - PDQ

    Time frame: Up to 1 year after start of treatment

    Validated clinical deficit scale PDQ will be compared relative to baseline scores

  8. Initial infection severity as a mediator of HBOT impact - FSS

    Time frame: Up to 1 year after start of treatment

    Validated clinical deficit scale FSS will be compared relative to baseline scores

  9. Initial infection severity as a mediator of HBOT impact - SF-36

    Time frame: Up to 1 year after start of treatment

    Validated clinical deficit scale SF-36 will be compared relative to baseline scores

  10. Long-term symptomatic impact at 1 year - PDQ

    Time frame: 12 month follow-up

    Assessed using validated clinical deficit scale PDQ at 12 months after start of treatment

  11. Long-term symptomatic impact at 1 year - FSS

    Time frame: 12 month follow-up

    Assessed using validated clinical deficit scale FSS at 12 months after start of treatment

  12. Long-term symptomatic impact at 1 year - SF-36

    Time frame: 12 month follow-up

    Assessed using validated clinical deficit scales SF-36 at 12 months after start of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Fahad Alam, MD

CONTACT

[email protected]

416-480-4864

Lilia Kaustov, PhD

CONTACT

[email protected]

416 480-6100 ext. 89607

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Acronym: PCS-HBOT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 13, 2023
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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