Clinical trial NCT06082518: Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments
Official title: Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments (PCS-HBOT Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post COVID-19 Condition
Post-COVID-19 Syndrome
Post-COVID Syndrome
COVID-19
Fatigue
Fatigue Syndrome, Chronic
Keywords: Hyperbaric Oxygen Therapy
HBOT
Post COVID-19 Condition
Fatigue
Severe Acute Respiratory Syndrome-CoV-2
COVID-19
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate - referral
timeFrame: 9 months
measure: Recruitment rate - inclusion
timeFrame: 9 months
measure: Recruitment rate - consent
timeFrame: 9 months
measure: Adherence to HBOT protocol
timeFrame: 9 months recruitment + 8 weeks treatment
measure: Adherence to HBOT protocol - satisfaction
timeFrame: After last HBOT treatment and at 12 month follow-up
measure: Feasibility of Clinical Outcome Measures
timeFrame: Up to 1 year after start of treatment
Secondary outcomes:
measure: The impact of HBOT on post COVID-19 condition - PDQ
timeFrame: Up to 1 year after start of treatment
measure: The impact of HBOT on post COVID-19 condition - FSS
timeFrame: Up to 1 year after start of treatment
measure: The impact of HBOT on post COVID-19 condition - SF-36
timeFrame: Up to 1 year after start of treatment
measure: The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ
timeFrame: Up to 1 year after start of treatment
measure: The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS
timeFrame: Up to 1 year after start of treatment
measure: The impact of time to initiation of HBOT on outcomes following initial infection outcome - SF-36
timeFrame: Up to 1 year after start of treatment
measure: Initial infection severity as a mediator of HBOT impact - PDQ
timeFrame: Up to 1 year after start of treatment
measure: Initial infection severity as a mediator of HBOT impact - FSS
timeFrame: Up to 1 year after start of treatment
measure: Initial infection severity as a mediator of HBOT impact - SF-36
timeFrame: Up to 1 year after start of treatment
measure: Long-term symptomatic impact at 1 year - PDQ
timeFrame: 12 month follow-up
measure: Long-term symptomatic impact at 1 year - FSS
timeFrame: 12 month follow-up
measure: Long-term symptomatic impact at 1 year - SF-36
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Fahad Alam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Jordan Tarshis, MD
role: PRINCIPAL_INVESTIGATOR
References: