Over 500 million people have been infected with COVID-19, and to date, more than 6million people have died. Many individuals who have recovered from COVID-19 continue toexperience symptoms even after they have been "cured" of the disease. This condition isknown as post COVID-19 condition, which can have serious health consequences. A commonsymptom among these individuals is chronic fatigue, characterized by persistent tirednessor lack of energy. This study aims to explore a novel treatment for symptoms of postCOVID-19 condition, known as hyperbaric oxygen therapy. This approach has shown promisein helping people with post COVID-19 conditions and treating some other causes offatigue.Hyperbaric oxygen therapy involves placing patients in a small chamber where they receivehigh oxygen gas levels. However, this treatment is expensive and time-consuming, and itis 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 postCOVID-19 condition, such as fatigue.
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.
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.
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
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Investigator: Fahad Alam, MD
Contact: 416-480-4864
fahad.alam@sunnybrook.ca
Fahad Alam, MD
416-480-4864
fahad.alam@sunnybrook.ca
Lilia Kaustov, PhD
416 480-6100 - 89607
lilia.kaustov@sunnybrook.ca