About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old
Officially diagnosed with post COVID-19 condition by a healthcare practitioner
At least three months since SARS-CoV-2 infection
Difficulty thinking or problem solving ('brain fog')
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Monoplace Hyperbaric Chamber (Class III medical device).
Device40 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.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment rate - referral
Quantify referral rate from healthcare providers
Recruitment rate - inclusion
Number of patients meeting inclusion criteria
Recruitment rate - consent
Patient consent rate
Adherence to HBOT protocol
Number of Participants received minimum 4 treatments per week with \>35 treatments
Secondary outcomes
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
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
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.
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
Sponsors and contacts
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