Hyperbaric oxygen therapy for Long COVID cognitive symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: reclaim@uhn.ca
• Phone: 1-866-673-2524

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hi-OxSR to treat post-COVID cognitive problems

  This trial will test whether using the Hi-OxSR breathing device can help adults with long COVID who have ongoing cognitive problems and fatigue.

  Recruiting at 3 sites University Health Network, Toronto · Edmonton, Alberta and 2 other locations · NCT06928506

• Combination therapy for Long COVID symptoms using valacyclovir, celecoxib, and Paxlovid

  This study tests whether a three-drug combination can reduce Long COVID symptoms in adults compared with a placebo.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07597902

• Mitochondrial oxygen use in blood, muscle, and skin of people with long COVID

  Researchers will test whether mitochondria use oxygen differently in blood cells, muscle, and skin of people with long COVID compared with people who fully recovered after COVID-19.

  Recruiting Universitair Ziekenhuis Brussel · Jette, Brussels Capital · NCT07134673

• Imaging brain inflammation in people with long COVID symptoms

  This study is testing if a brain scan can show signs of inflammation in people aged 18 to 70 who have neurological symptoms after COVID-19, and whether a treatment called IVIg can help them feel better.

  Recruiting Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06920628

• Rehabilitation program to reduce fatigue after COVID-19

  This study is testing a new rehabilitation program called COVIDEx to see if it can help people with Long COVID feel less tired compared to standard care.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT06156176

• Mind-body intervention for people with Long COVID

  This study is testing a mind-body program to see if it can help people with Long COVID feel better and improve their daily activities.

  Recruiting Beth Israel Deaconess Medical Center · Boston, Massachusetts · NCT06045338

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.