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Hyperbaric Oxygen Therapy for Long COVID (PCS-HBOT Trial)

N/A
Recruiting
Led By Fahad Alam, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Officially diagnosed with post COVID-19 condition by a healthcare practitioner
Must not have
Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after last hbot treatment and at 12 month follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial is exploring a new treatment for post COVID-19 symptoms, such as fatigue, using hyperbaric oxygen therapy. The findings could help decide if this treatment is feasible for a large-scale research study.

Who is the study for?
Adults diagnosed with post COVID-19 condition, experiencing chronic fatigue and at least one other symptom like 'brain fog' or anxiety for over 12 weeks since infection. Excludes those with traumatic brain injury, unstable living situations, pregnant women or those planning pregnancy, pre-existing cognitive issues, and anyone unfit for hyperbaric treatments.
What is being tested?
The trial is testing hyperbaric oxygen therapy—a treatment where patients breathe high levels of oxygen in a special chamber—to see if it can alleviate symptoms of post COVID-19 condition such as persistent fatigue and 'brain fog'.
What are the potential side effects?
While not specified here, common side effects of hyperbaric oxygen therapy may include ear pressure changes leading to discomfort or pain, temporary vision changes, and rarely lung collapse due to air pressure changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been officially diagnosed with long COVID.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am medically fit for hyperbaric treatments and do not have conditions like pneumothorax or unstable heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after last hbot treatment and at 12 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and after last hbot treatment and at 12 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to HBOT protocol
Adherence to HBOT protocol - satisfaction
Feasibility of Clinical Outcome Measures
+3 more
Secondary study objectives
Initial infection severity as a mediator of HBOT impact - FSS
Initial infection severity as a mediator of HBOT impact - PDQ
Initial infection severity as a mediator of HBOT impact - SF-36
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Immediate start of hyperbaric treatmentsExperimental Treatment1 Intervention
HBOT treatments will be scheduled to start immediately after referral.
Group II: Delayed start of hyperbaric treatmentsExperimental Treatment1 Intervention
HBOT treatments will be scheduled to start 60 days after referral.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,449 Total Patients Enrolled
Fahad Alam, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
Jordan Tarshis, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
~23 spots leftby Dec 2025
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