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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 years;

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.

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.

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;

Disqualifiers

Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;

Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;

Contraindications to all of the study interventions;

Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);

Trial design

Treatments tested in this trial

  • Hyperbaric Oxygen therapy

Treatment groups

120 Participants
are divided into 2 treatment groups