Post COVID-19 ConditionPCS-HBOTNCT06082518
Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments
A study testing Monoplace Hyperbaric Chamber (Class III medical device). in people with Post COVID-19 Condition and Post-COVID-19 Syndrome, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID-19 Condition, Post-COVID-19 Syndrome, Post-COVID Syndrome
- What is being tested?
- Monoplace Hyperbaric Chamber (Class III medical device).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Known pregnancy or planning a pregnancy in women of childbearing age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments (PCS-HBOT Study)
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.
Read the 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.
- Conditions
- Post COVID-19 Condition, Post-COVID-19 Syndrome, Post-COVID Syndrome, COVID-19, Fatigue, Fatigue Syndrome, Chronic
- Being tested
- Monoplace Hyperbaric Chamber (Class III medical device).
- Keywords
- Hyperbaric Oxygen Therapy, HBOT, Post COVID-19 Condition, Fatigue, Severe Acute Respiratory Syndrome-CoV-2, COVID-19
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Fatigue, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate start of hyperbaric treatments | Experimental | HBOT treatments will be scheduled to start immediately after referral. Receives: Device: Monoplace Hyperbaric Chamber (Class III medical device). |
| Delayed start of hyperbaric treatments | Experimental | HBOT treatments will be scheduled to start 60 days after referral. Receives: Device: Monoplace Hyperbaric Chamber (Class III medical device). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate - referral
Quantify referral rate from healthcare providers
Measured: 9 months
Recruitment rate - inclusion
Number of patients meeting inclusion criteria
Measured: 9 months
Recruitment rate - consent
Patient consent rate
Measured: 9 months
Adherence to HBOT protocol
Number of Participants received minimum 4 treatments per week with >35 treatments
Measured: 9 months recruitment + 8 weeks treatment
Adherence to HBOT protocol - satisfaction
Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment
Measured: After last HBOT treatment and at 12 month follow-up
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.
Measured: Up to 1 year after start of treatment
Secondary outcomes (12)
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
Measured: Up to 1 year after start of treatment
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
Measured: Up to 1 year after start of treatment
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.
Measured: Up to 1 year after start of treatment
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
Measured: Up to 1 year after start of treatment
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
Measured: Up to 1 year after start of treatment
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
Measured: Up to 1 year after start of treatment
Initial infection severity as a mediator of HBOT impact - PDQ
Validated clinical deficit scale PDQ will be compared relative to baseline scores
Measured: Up to 1 year after start of treatment
Initial infection severity as a mediator of HBOT impact - FSS
Validated clinical deficit scale FSS will be compared relative to baseline scores
Measured: Up to 1 year after start of treatment
Initial infection severity as a mediator of HBOT impact - SF-36
Validated clinical deficit scale SF-36 will be compared relative to baseline scores
Measured: Up to 1 year after start of treatment
Long-term symptomatic impact at 1 year - PDQ
Assessed using validated clinical deficit scale PDQ at 12 months after start of treatment
Measured: 12 month follow-up
Long-term symptomatic impact at 1 year - FSS
Assessed using validated clinical deficit scale FSS at 12 months after start of treatment
Measured: 12 month follow-up
Long-term symptomatic impact at 1 year - SF-36
Assessed using validated clinical deficit scales SF-36 at 12 months after start of treatment
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start2 Jan 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fahad Alam, MD, Principal investigator, Sunnybrook Health Sciences CentreJordan Tarshis, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082518
- Sponsor's protocol ID
- 5825
- Acronym
- PCS-HBOT
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be available upon request to study PIs following publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments (PCS-HBOT Study)
- ClinicalTrials.gov ID
- NCT06082518
- Acronym / sponsor ID
- PCS-HBOT / 5825
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate start of hyperbaric treatments | Experimental | Device: Monoplace Hyperbaric Chamber (Class III medical device).HBOT treatments will be scheduled to start immediately after referral. |
| Delayed start of hyperbaric treatments | Experimental | Device: Monoplace Hyperbaric Chamber (Class III medical device).HBOT treatments will be scheduled to start 60 days after referral. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- 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)
- Known pregnancy or planning a pregnancy in women of childbearing age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Delayed start of hyperbaric treatments, Immediate start of hyperbaric treatments |
Primary outcome
Recruitment rate - referral
Time frame: 9 months
Quantify referral rate from healthcare providers
Recruitment rate - inclusion
Time frame: 9 months
Number of patients meeting inclusion criteria
Recruitment rate - consent
Time frame: 9 months
Patient consent rate
Adherence to HBOT protocol
Time frame: 9 months recruitment + 8 weeks treatment
Number of Participants received minimum 4 treatments per week with >35 treatments
Adherence to HBOT protocol - satisfaction
Time frame: After last HBOT treatment and at 12 month follow-up
Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment
Feasibility of Clinical Outcome Measures
Time frame: Up to 1 year after start of treatment
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.
12 secondary outcomes
The impact of HBOT on post COVID-19 condition - PDQ
Time frame: Up to 1 year after start of treatment
The impact of HBOT on post COVID-19 condition - FSS
Time frame: Up to 1 year after start of treatment
The impact of HBOT on post COVID-19 condition - SF-36
Time frame: Up to 1 year after start of treatment
The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ
Time frame: Up to 1 year after start of treatment
The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS
Time frame: Up to 1 year after start of treatment
The impact of time to initiation of HBOT on outcomes following initial infection outcome - SF-36
Time frame: Up to 1 year after start of treatment
Initial infection severity as a mediator of HBOT impact - PDQ
Time frame: Up to 1 year after start of treatment
Initial infection severity as a mediator of HBOT impact - FSS
Time frame: Up to 1 year after start of treatment
Initial infection severity as a mediator of HBOT impact - SF-36
Time frame: Up to 1 year after start of treatment
Long-term symptomatic impact at 1 year - PDQ
Time frame: 12 month follow-up
Long-term symptomatic impact at 1 year - FSS
Time frame: 12 month follow-up
Long-term symptomatic impact at 1 year - SF-36
Time frame: 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be available upon request to study PIs following publication.
Related trials for Post COVID-19 Condition
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Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
RecruitingPhase 2
DAOIB for the Treatment of Brain Fog
Long COVID
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahad Alam, MD principal investigator
Sunnybrook Health Sciences Centre
Jordan Tarshis, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monoplace Hyperbaric Chamber (Class III medical device). in people with Post COVID-19 Condition and Post-COVID-19 Syndrome, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate - referral (time frame: 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.