Hyperbaric oxygen therapy for Long COVID cognitive symptoms

RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hyperbaric Oxygen Therapy for the Treatment of Post COVID Condition (RECLAIM-HBOT)

This study will test whether hyperbaric oxygen therapy can improve lingering cognitive symptoms like brain fog and memory problems in adults who had COVID-19.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06452095 on ClinicalTrials.gov

What this trial studies

The RECLAIM platform will enroll adults with confirmed or presumed COVID-19 who have had persistent cognitive symptoms for at least three months. Participants will receive a course of protocolized hyperbaric oxygen therapy sessions delivered in a hyperbaric chamber, with symptom and cognitive outcomes measured over follow-up. HBOT delivers high concentrations of oxygen that can promote new blood vessel growth, modulate immune and inflammatory responses, and protect nervous tissue—mechanisms thought to underlie some Long COVID problems. The trial will compare participant outcomes on standardized cognitive and symptom measures to determine whether HBOT provides clinically meaningful improvement.

Who should consider this trial

Good fit: Adults aged 18 or older with confirmed or presumed COVID-19 at least three months earlier who continue to have self-reported cognitive dysfunction for at least two months despite standard care are the intended participants.

Not a fit: People without persistent cognitive symptoms, with symptoms for less than three months, or with contraindications to hyperbaric oxygen therapy (for example certain untreated lung or ear conditions) are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, HBOT could reduce brain fog, fatigue, and other vascular- or inflammation-related Long COVID symptoms by improving oxygen delivery and reducing inflammation.

How similar studies have performed: Small pilot and observational studies have reported preliminary improvements with HBOT for some Long COVID symptoms, but larger randomized data are still limited and inconclusive.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years;
2. Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019.
3. Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.
4. Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms;
5. Lingering symptoms from COVID-19 present at the time of randomization. "Lingering symptoms of Long COVID" must include self-reported cognitive dysfunction symptoms.
6. Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. Effective methods of contraception must be discussed and approved by the overseeing Investigator.
7. Must be able to provide informed consent and both willing and able to comply with study requirements.
8. A confirmed ability to travel to one of the three sites where HBOT or sham can be administered.

Exclusion Criteria:

1. Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
2. Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
3. Contraindications to all of the study interventions;
4. Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);
5. Currently pregnant or breastfeeding.
6. Pneumothorax
7. Poorly controlled seizure disorder
8. Chronic sinusitis
9. Chronic or acute otitis media
10. Major ear drum trauma.

Where this trial is running

Toronto, Ontario

• University Health Network — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Rita Katznelson, MD — University Health Network, Toronto
• Study coordinator: RECLAIM CONTACT RECLAIM contact line

Conditions: Long COVID, Post Acute Sequelae of COVID-19, Post-COVID-19 Condition