Official Title
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)
Brief Summary

The RECLAIM study platform will be used to explore whether the use of Hyperbaric Oxygentherapy (HBOT) improves the symptoms of post covid cognitive dysfunction.Hyperbaric oxygen therapy is a well-established medical treatment. HBOT promotes healingby delivering a high concentration of oxygen into the body. This high level of oxygen hasa number of known benefits, such as growth of new blood vessels, as well as regulatingimmune and inflammation responses. It helps protect the brain and other nervous tissuefrom inflammation. HBOT may also have antiviral effects.Collectively, it has the potential to target the underlying mechanisms believed to play acritical role in the development of Long COVID.Many individuals with Long COVID complain of fatigue, brain fog, muscle aches and othersymptoms. There is evidence to suggest that these symptoms may be a problem with theblood vessels, resulting in abnormal delivery of oxygen to tissues. Thus, our group isinvestigating whether HBOT improves post-COVID cognitive dysfunction.

Detailed Description

This is a Sub-Protocol to the Core Clinical Study Protocol titled: REcovering from
COVID19 Lingering symptoms Adaptive Integrative Medicine (RECLAIM),

Not yet recruiting
Long Covid
Post Acute Sequelae of COVID-19
Post-COVID-19 Condition

Device: Hyperbaric Oxygen therapy

The SECHRIST INDUSTRIES mono-place Hyperbaric Chambers OR Sigma Series mono-place
Hyperbaric Chambers

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Locations

Not Provided

Contacts

RECLAIM CONTACT RECLAIM contact line
1-866-673-2524
reclaim@uhn.ca

Andrew Janes, MSc
andrew.janes@uhn.ca

University Health Network, Toronto
NCT Number
MeSH Terms
Post-Acute COVID-19 Syndrome
Hyperbaric Oxygenation