PCS-HBOT: Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06082518

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post COVID-19 Condition Post-COVID-19 Syndrome Post-COVID Syndrome COVID-19 Fatigue Fatigue Syndrome, Chronic	Device: Monoplace Hyperbaric Chamber (Class III medical device).	N/A

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 90-day interval. All patients will be followed for 12 months from the initial treatment referral, with monthly assessments of post-COVID-19 condition symptoms (e.g. quality of life, fatigue) and participant satisfaction.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

Specialist hyperbaric physicians, blinded to group allocation, will provide treatment and follow patients daily throughout their treatment course. Outcomes Assessor will also be blinded to group allocation.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate start of hyperbaric treatments HBOT treatments will be scheduled to start immediately after referral.	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.
Experimental: Delayed start of hyperbaric treatments HBOT treatments will be scheduled to start 90 days after referral.	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.

Arm

Intervention/Treatment

Experimental: Immediate start of hyperbaric treatments

HBOT treatments will be scheduled to start immediately after referral.

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.

Experimental: Delayed start of hyperbaric treatments

HBOT treatments will be scheduled to start 90 days after referral.

Device: Monoplace Hyperbaric Chamber (Class III medical device).

Outcome Measures

Primary Outcome Measures

Recruitment rate - referral [9 months]
Quantify referral rate from healthcare providers
Recruitment rate - inclusion [9 months]
Number of patients meeting inclusion criteria
Recruitment rate - consent [9 months]
Patient consent rate
Adherence to HBOT protocol [9 months recruitment + 12 month follow-up]
Number of Participants received minimum 4 treatments per week with >35 treatments
Adherence to HBOT protocol - satisfaction [every 2-month intervals over 12 month follow-up]
Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment

Secondary Outcome Measures

The impact of HBOT on post COVID-19 condition - PDQ [Every two month until 1 year after treatment referral and completing HBOT treatments]
The validated clinical deficit scale will be used: Perceived Deficits Questionnaire (PDQ)
The impact of HBOT on post COVID-19 condition - FSS [Every two month until 1 year after treatment referral and completing HBOT treatments]
The validated clinical deficit scale will be used: Fatigue Severity Scale (FSS)
The impact of HBOT on post COVID-19 condition - SF-36 [Every two month until 1 year after treatment referral and completing HBOT treatments]
The validated clinical deficit scale will be used: QoL Short Form Survey (SF-36)
The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ [Every two month until 1 year after treatment referral]
Validated clinical deficit scales PDQ will be compared with FSS and SF-36 between immediate and delayed start groups
The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS [Every two month until 1 year after treatment referral]
Validated clinical deficit scale FSS will be compared with PDQ and SF-36 between immediate and delayed start groups
The impact of time to initiation of HBOT on outcomes following initial infection outcome - SF-36 [Every two month until 1 year after treatment referral]
Validated clinical deficit scale SF-36 will be compared with PDQ and FSS between immediate and delayed start groups
Initial infection severity as a mediator of HBOT impact - PDQ [Every two month until 1 year after treatment referral]
Validated clinical deficit scale PDQ will be compared relative to baseline scores
Initial infection severity as a mediator of HBOT impact - FSS [Every two month until 1 year after treatment referral]
Validated clinical deficit scale FSS will be compared relative to baseline scores
Initial infection severity as a mediator of HBOT impact - SF-36 [Every two month until 1 year after treatment referral]
Validated clinical deficit scale SF-36 will be compared relative to baseline scores
Long-term symptomatic impact at 1 year - PDQ [12 month follow-up]
Assessed using validated clinical deficit scale PDQ at 12 months after treatment referral
Long-term symptomatic impact at 1 year - FSS [12 month follow-up]
Assessed using validated clinical deficit scale FSS at 12 months after treatment referral
Long-term symptomatic impact at 1 year - SF-36 [12 month follow-up]
Assessed using validated clinical deficit scales SF-36 at 12 months after treatment referral

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Known pregnancy or planning a pregnancy in women of childbearing age

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) 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)