Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

COVID-19 Clinical Trial

— PCS-HBOT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06082518
• Other study ID #: 5825
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Fahad Alam, MD
• Phone: 416-480-4864
• Email: fahad.alam[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Fatigue
• Fatigue Syndrome, Chronic
• Post-COVID-19 Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate - referral	Quantify referral rate from healthcare providers	9 months
Primary	Recruitment rate - inclusion	Number of patients meeting inclusion criteria	9 months
Primary	Recruitment rate - consent	Patient consent rate	9 months
Primary	Adherence to HBOT protocol	Number of Participants received minimum 4 treatments per week with >35 treatments	9 months recruitment + 8 weeks treatment
Primary	Adherence to HBOT protocol - satisfaction	Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment	After last HBOT treatment and at 12 month follow-up
Primary	Feasibility of Clinical Outcome Measures	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.	Up to 1 year after start of treatment
Secondary	The impact of HBOT on post COVID-19 condition - PDQ	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	Up to 1 year after start of treatment
Secondary	The impact of HBOT on post COVID-19 condition - FSS	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	Up to 1 year after start of treatment
Secondary	The impact of HBOT on post COVID-19 condition - SF-36	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.	Up to 1 year after start of treatment
Secondary	The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ	Validated clinical deficit scales PDQ will be compared with FSS and SF-36 between immediate and delayed start groups	Up to 1 year after start of treatment
Secondary	The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS	Validated clinical deficit scale FSS will be compared with PDQ and SF-36 between immediate and delayed start groups	Up to 1 year after start of treatment
Secondary	The impact of time to initiation of HBOT on outcomes following initial infection outcome - SF-36	Validated clinical deficit scale SF-36 will be compared with PDQ and FSS between immediate and delayed start groups	Up to 1 year after start of treatment
Secondary	Initial infection severity as a mediator of HBOT impact - PDQ	Validated clinical deficit scale PDQ will be compared relative to baseline scores	Up to 1 year after start of treatment
Secondary	Initial infection severity as a mediator of HBOT impact - FSS	Validated clinical deficit scale FSS will be compared relative to baseline scores	Up to 1 year after start of treatment
Secondary	Initial infection severity as a mediator of HBOT impact - SF-36	Validated clinical deficit scale SF-36 will be compared relative to baseline scores	Up to 1 year after start of treatment
Secondary	Long-term symptomatic impact at 1 year - PDQ	Assessed using validated clinical deficit scale PDQ at 12 months after start of treatment	12 month follow-up
Secondary	Long-term symptomatic impact at 1 year - FSS	Assessed using validated clinical deficit scale FSS at 12 months after start of treatment	12 month follow-up
Secondary	Long-term symptomatic impact at 1 year - SF-36	Assessed using validated clinical deficit scales SF-36 at 12 months after start of treatment	12 month follow-up