Clinical trial NCT06452095: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long COVID
Post Acute Sequelae of COVID-19
Post-COVID-19 Condition
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RECLAIM is a Canada-wide phase ll/lll, prospective, adaptive randomized controlled platform trial that is intended to study various interventions for patients with long COVID. Interventional arms may be discontinued based on interim analysis results and new interventions may be selected and included as part of the platform as the trial progresses. As such, the protocol and consent documents are a modular design.

The HBOT arm includes:

* Master Protocol and informed consent documents: Contain information applicable to the whole platform.
* HBOT Sub-Protocol: Contain additional information, specific to the HBOT interventional arm.
Primary purpose: TREATMENT

Brief summary: 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),

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.

Primary outcomes:
measure: Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit
timeFrame: Baseline/Start of intervention to two months
measure: Verbal paired associates [VPA] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit
timeFrame: Baseline/Start of intervention to two months
Secondary outcomes:
measure: Symptoms scale
timeFrame: Baseline/start of intervention weekly to 2 months, then once monthly to 6 months.
measure: Symptom Checklist
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: Six Minute Walking Test (6MWT) with oximetry
timeFrame: Baseline/start of intervention and 2 months.
measure: SF-36
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: TestMyBrain cognitive testing
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: Post COVID19 functional status scale
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: The Fatigue Scale
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: Brief Fatigue inventory
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: Post-Exertional Malaise
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: Mental Health - General Anxiety Assessment Form (GAD-7)
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: Mental Health - Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: Dyspnea
timeFrame: Baseline/start of intervention to 1, 2 months 3 and 6 months
measure: Blood samples
timeFrame: Baseline/start of intervention and 2 months
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Angela M Cheung, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Health Network, Toronto
name: Rita Katznelson, MD
role: PRINCIPAL_INVESTIGATOR
References: