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

University Health Network, Toronto

Status: Begins enrollment this month

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

Treatments: Device: Hyperbaric Oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06452095

21-6203-HBOT

Details and patient eligibility

About

The RECLAIM study platform will be used to explore whether the use of Hyperbaric Oxygen therapy (HBOT) improves the symptoms of post covid cognitive dysfunction.

Hyperbaric oxygen therapy is a well-established medical treatment. HBOT promotes healing by delivering a high concentration of oxygen into the body. This high level of oxygen has a number of known benefits, such as growth of new blood vessels, as well as regulating immune and inflammation responses. It helps protect the brain and other nervous tissue from inflammation. HBOT may also have antiviral effects.

Collectively, it has the potential to target the underlying mechanisms believed to play a critical role in the development of Long COVID.

Many individuals with Long COVID complain of fatigue, brain fog, muscle aches and other symptoms. There is evidence to suggest that these symptoms may be a problem with the blood vessels, resulting in abnormal delivery of oxygen to tissues. Thus, our group is investigating whether HBOT improves post-COVID cognitive dysfunction.

Full description

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Hyperbaric oxygen therapy

Experimental group

Description:

HBOT GROUP will have HBOT with 100% oxygen for 90 min, once daily, five times a week for 8 consecutive weeks. This will be given at a slightly higher pressure than normal air pressure (2 times regular air pressure)

Treatment:

Device: Hyperbaric Oxygen therapy

Hyperbaric oxygen sham

Sham Comparator group

Description:

CONTROL GROUP will have sham treatment, which will look and feel like HBOT, but will not have high enough oxygen concentration for any therapeutic or health benefit. Sham treatment with 21% oxygen (the amount of oxygen normally present in the air) for 90 min, once daily, five times a week for 8 consecutive weeks. This will be given at standard atmospheric pressure (1.03 ATA). The air pressure will vary slightly to mimic the feeling of HBOT.

Treatment:

Device: Hyperbaric Oxygen therapy