Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Monoplace Hyperbaric Chamber (Class III medical device).

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Immediate start of hyperbaric treatmentsExperimental treatment 1 intervention
Group B: Delayed start of hyperbaric treatmentsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate - referral

Quantify referral rate from healthcare providers

Time frame
9 months
2

Recruitment rate - inclusion

Number of patients meeting inclusion criteria

Time frame
9 months
3

Recruitment rate - consent

Patient consent rate

Time frame
9 months
4

Adherence to HBOT protocol

Number of Participants received minimum 4 treatments per week with \>35 treatments

Time frame
9 months recruitment + 8 weeks treatment

Secondary outcomes

1

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

Time frame
Up to 1 year after start of treatment
2

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

Time frame
Up to 1 year after start of treatment
3

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.

Time frame
Up to 1 year after start of treatment
4

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

Time frame
Up to 1 year after start of treatment

Other outcomes

Sponsors and contacts

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