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

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)

Overview

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.

Detailed description

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

Interventions

• Device Hyperbaric Oxygen therapy
  The SECHRIST INDUSTRIES mono-place Hyperbaric Chambers OR Sigma Series mono-place Hyperbaric Chambers

Primary outcome measures

• Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit [Time frame: Baseline/Start of intervention to two months]
• Verbal paired associates [VPA] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit [Time frame: Baseline/Start of intervention to two months]

Secondary outcome measures (12)

• Symptoms scale [Time frame: Baseline/start of intervention weekly to 2 months, then once monthly to 6 months.]
• Symptom Checklist [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]
• Six Minute Walking Test (6MWT) with oximetry [Time frame: Baseline/start of intervention and 2 months.]
• SF-36 [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]
• TestMyBrain cognitive testing [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]
• Post COVID19 functional status scale [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]
• Reintegration to Normal Living Index (RNLI) [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]
• The Fatigue Scale [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]
• Brief Fatigue inventory [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]
• Post-Exertional Malaise [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]
• Mental Health - General Anxiety Assessment Form (GAD-7) [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]
• Mental Health - Patient Health Questionnaire (PHQ-9) [Time frame: Baseline/start of intervention to 1, 2 months 3 and 6 months]

Eligibility criteria

Inclusion criteria

• 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;
• Lingering symptoms from COVID-19 present at the time of randomization. "Lingering symptoms of Long COVID" must include self-reported cognitive dysfunction symptoms.
• 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.
• Must be able to provide informed consent and both willing and able to comply with study requirements.
• A confirmed ability to travel to one of the three sites where HBOT or sham can be administered.

Exclusion criteria

• 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);
• Currently pregnant or breastfeeding.
• Pneumothorax
• Poorly controlled seizure disorder
• Chronic sinusitis
• Chronic or acute otitis media
• Major ear drum trauma.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• University Health Network — Toronto

Identifiers

NCT: NCT06452095 · 21-6203-HBOT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗