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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.
This is a Sub-Protocol to the Core Clinical Study Protocol titled: REcovering from COVID19 Lingering symptoms Adaptive Integrative Medicine (RECLAIM),
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric oxygen therapy | Experimental | 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) |
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| Hyperbaric oxygen sham | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen therapy | Device | The SECHRIST INDUSTRIES mono-place Hyperbaric Chambers OR Sigma Series mono-place Hyperbaric Chambers |
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| Measure | Description | Time Frame |
|---|---|---|
| Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit | On-line survey tool | Baseline/Start of intervention to two months |
| Verbal paired associates [VPA] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit | On-line survey tool | Baseline/Start of intervention to two months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms scale | Three point Likert scale assessing how bothersome symptoms are on a weekly basis for two months then monthly until end of study, as reported by the participant: to provide a granular, detailed picture of the symptom trajectory. | Baseline/start of intervention weekly to 2 months, then once monthly to 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RECLAIM CONTACT RECLAIM contact line | Contact | 1-866-673-2524 | reclaim@uhn.ca | |
| Andrew Janes, MSc | Contact | andrew.janes@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Angela M Cheung, MD, PhD | University Health Network, Toronto | Study Director |
| Rita Katznelson, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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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:
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Participants are blinded to intervention in so far as the HBOT experience will be similar between treatment and sham arms.
| Symptom Checklist |
Symptom Checklist (adapted from the De Paul Symptom Questionnaire (DSQ2), the World Health Organization Global COVID-19 Clinical Platform's Post COVID-19 CRF and the Symptom Burden Questionnaire for Long COVID): to track symptom trajectory. |
| Baseline/start of intervention to 1, 2 months 3 and 6 months |
| Six Minute Walking Test (6MWT) with oximetry | Subjects walk as far as they can in six minutes while receiving maximum encouragement. It is simple to execute, inexpensive, standardized and gives a tangible measure of functional exercise capacity. It has been validated in many different populations. The 6MWT will be conducted according to American Thoracic Society standards. | Baseline/start of intervention and 2 months. |
| SF-36 | The self-administered SF-36 evaluates eight health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning-emotional, and mental health. Previous studies have used this instrument in many different populations and it takes approximately 15 minutes to complete. | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| TestMyBrain cognitive testing | TestMyBrain was developed as a tool to collect large, population-based samples for understanding the relationship between cognition, emotion, social functioning, and health. This test battery includes: TMB Verbal Paired Associates (Concrete), TMB Digit Span - Backward, TMB Digit Span - Forward, TMB Choice Reaction Time, TMB Simple Reaction Time, TMB Gradual Onset Continuous Performance Task. The test battery will take about 20 minutes to complete and will assess: verbal, episodic and working memory, attention, processing speed, basic psychomotor response speed, and cognitive control. | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| Post COVID19 functional status scale | The post-COVID-19 functional status (PCFS) scale focuses on relevant aspects of daily life during follow-up after the infection. The scale is intended to help users become aware of current functional limitations in COVID-19 patients, whether or not as a result of the specific infection, and to objectively determine this degree of disability. The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle. The PCFS demonstrates good construct validity. | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| Reintegration to Normal Living Index (RNLI) | This short self-administered assessment tool will determine the degree to which participants reintegrate into normal social activities such as recreation, mobility in the community and interaction in family and other relationships. This tool has been validated in community living adults with mobility limitations. | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| The Fatigue Scale | The Fatigue Scale was adapted from the De Paul Symptom Questionnaire (DSQ2)'s 38 questions assessing medical history of Myalgic Encephalitis/Chronic Fatigue Syndrome (ME/CFS), comorbidities, medications, impact on quality of life and daily activities, etc. | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| Brief Fatigue inventory | The self-administered Brief Fatigue Inventory is composed of 9 items evaluated on a 10-point scale, assessing severity of fatigue and impact of fatigue on daily life. It takes approximately 2-3 minutes to complete. | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| Post-Exertional Malaise | The self-administered DPEMQ is comprised of three sections assessing post-exertional malaise (PEM): (i) onset and triggers of PEM (9 questions), (ii) consequences and symptoms (14 questions), (iii) duration, recovery and pacing (7 questions). | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| Mental Health - General Anxiety Assessment Form (GAD-7) | The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. It is an easy-to-use, self-administered patient questionnaire that can be completed in minutes. | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| Mental Health - Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a validated, multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It incorporates Diagnostic and Statistical Manual 1V (DSM-IV) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The PHQ-9 is brief and useful in clinical practice. | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| Dyspnea | Assessed using the Borg Dyspnea scale. This short assessment tool assesses perceived shortness of breath on exertion using a 10 point scale as assessed by the patient. | Baseline/start of intervention to 1, 2 months 3 and 6 months |
| Blood samples | Blood samples will be used in correlative studies using advanced multi-omic and machine learning techniques to better understand our results so as to identify phenotypes that will benefit from specific therapies | Baseline/start of intervention and 2 months |
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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