Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT06082518
Status:
RECRUITING
Last Update Posted:
2025-01-15
First Post:
2023-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Specialist hyperbaric physicians, blinded to group allocation, will provide treatment and follow patients daily throughout their treatment course.\n\nOutcomes Assessor will also be blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-10-12', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate - referral', 'timeFrame': '9 months', 'description': 'Quantify referral rate from healthcare providers'}, {'measure': 'Recruitment rate - inclusion', 'timeFrame': '9 months', 'description': 'Number of patients meeting inclusion criteria'}, {'measure': 'Recruitment rate - consent', 'timeFrame': '9 months', 'description': 'Patient consent rate'}, {'measure': 'Adherence to HBOT protocol', 'timeFrame': '9 months recruitment + 8 weeks treatment', 'description': 'Number of Participants received minimum 4 treatments per week with \\>35 treatments'}, {'measure': 'Adherence to HBOT protocol - satisfaction', 'timeFrame': 'After last HBOT treatment and at 12 month follow-up', 'description': 'Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment'}, {'measure': 'Feasibility of Clinical Outcome Measures', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'Feasibility of implementation of clinical outcome scales (PDQ, FSS, SF-36) to be completed at the time of enrollment (baseline), start of treatment (if starting 60 days after enrollment), 4 weeks after the start of treatment, and every 2 months from the first HBOT treatment for 1 year.'}], 'secondaryOutcomes': [{'measure': 'The impact of HBOT on post COVID-19 condition - PDQ', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'The validated clinical deficit scale, Perceived Deficits Questionnaire (PDQ), will be used at the time of enrollment (baseline), start of treatment (if starting 60 days after enrollment), 4 weeks after the start of treatment, and every 2 months from the first HBOT treatment for 1 year'}, {'measure': 'The impact of HBOT on post COVID-19 condition - FSS', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'The validated clinical deficit scale, Fatigue Severity Scale (FSS), will be used at the time of enrollment (baseline), start of treatment (if starting 60 days after enrollment), 4 weeks after the start of treatment, and every 2 months from the first HBOT treatment for 1 year'}, {'measure': 'The impact of HBOT on post COVID-19 condition - SF-36', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'The validated clinical deficit scale, QoL Short Form Survey (SF-36), will be used at the time of enrollment (baseline), start of treatment (if starting 60 days after enrollment), 4 weeks after the start of treatment, and every 2 months from the first HBOT treatment for 1 year.'}, {'measure': 'The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'Validated clinical deficit scales PDQ will be compared with FSS and SF-36 between immediate and delayed start groups'}, {'measure': 'The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'Validated clinical deficit scale FSS will be compared with PDQ and SF-36 between immediate and delayed start groups'}, {'measure': 'The impact of time to initiation of HBOT on outcomes following initial infection outcome - SF-36', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'Validated clinical deficit scale SF-36 will be compared with PDQ and FSS between immediate and delayed start groups'}, {'measure': 'Initial infection severity as a mediator of HBOT impact - PDQ', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'Validated clinical deficit scale PDQ will be compared relative to baseline scores'}, {'measure': 'Initial infection severity as a mediator of HBOT impact - FSS', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'Validated clinical deficit scale FSS will be compared relative to baseline scores'}, {'measure': 'Initial infection severity as a mediator of HBOT impact - SF-36', 'timeFrame': 'Up to 1 year after start of treatment', 'description': 'Validated clinical deficit scale SF-36 will be compared relative to baseline scores'}, {'measure': 'Long-term symptomatic impact at 1 year - PDQ', 'timeFrame': '12 month follow-up', 'description': 'Assessed using validated clinical deficit scale PDQ at 12 months after start of treatment'}, {'measure': 'Long-term symptomatic impact at 1 year - FSS', 'timeFrame': '12 month follow-up', 'description': 'Assessed using validated clinical deficit scale FSS at 12 months after start of treatment'}, {'measure': 'Long-term symptomatic impact at 1 year - SF-36', 'timeFrame': '12 month follow-up', 'description': 'Assessed using validated clinical deficit scales SF-36 at 12 months after start of treatment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hyperbaric Oxygen Therapy', 'HBOT', 'Post COVID-19 Condition', 'Fatigue', 'Severe Acute Respiratory Syndrome-CoV-2', 'COVID-19'], 'conditions': ['Post COVID-19 Condition', 'Post-COVID-19 Syndrome', 'Post-COVID Syndrome', 'COVID-19', 'Fatigue', 'Fatigue Syndrome, Chronic']}, 'descriptionModule': {'briefSummary': 'Over 500 million people have been infected with COVID-19, and to date, more than 6 million people have died. Many individuals who have recovered from COVID-19 continue to experience symptoms even after they have been "cured" of the disease. This condition is known as post COVID-19 condition, which can have serious health consequences. A common symptom among these individuals is chronic fatigue, characterized by persistent tiredness or lack of energy. This study aims to explore a novel treatment for symptoms of post COVID-19 condition, known as hyperbaric oxygen therapy. This approach has shown promise in helping people with post COVID-19 conditions and treating some other causes of fatigue.\n\nHyperbaric oxygen therapy involves placing patients in a small chamber where they receive high oxygen gas levels. However, this treatment is expensive and time-consuming, and it is unclear if this treatment can be effectively assessed in a large-scale research study. This small study will help us decide if conducting a large research study is feasible. The investigators aim to assess if hyperbaric oxygen therapy can improve symptoms of post COVID-19 condition, such as fatigue.', 'detailedDescription': "Over 500 million individuals worldwide have contracted COVID-19. Among those that have 'recovered' from the acute infection, many suffer from post-COVID-19 condition (experiencing 1 or more symptoms 3 months from the onset of acute COVID-19 infection, with symptoms lasting at least 2 months). Many of these common symptoms, including fatigue, myalgia, and difficulty focusing ('brain fog'), can seriously compromise one's quality of life.\n\nExisting treatments predominantly focus on supportive management and specific symptom control, and most approaches have mixed or limited effectiveness. Recently, hyperbaric oxygen therapy (HBOT), acknowledged for its anti-inflammatory effects, has emerged as a potential treatment for post-COVID-19 condition symptoms. However, HBOT is time and resource-intensive, requiring between 20-40 daily treatments. Therefore, the feasibility of assessing HBOT efficacy via a large-scale randomized controlled trial is still being determined. Hence, this study aims to evaluate adherence to the protocol and the feasibility of proceeding with the full trial. The goal of the full trial will be to evaluate the impact of HBOT treatment on post-COVID-19 condition symptoms.\n\nThis prospective, crossover, randomized pilot trial enrolls adult patients officially diagnosed with post-COVID-19 condition by a healthcare practitioner who continue to experience symptoms, particularly fatigue, at least 3 months following their initial COVID-19 infection. Participants will be assigned randomly (stratified by sex) to either begin HBOT treatments immediately or after a 60-day interval. All patients will be followed for 12 months from the start of treatment, with assessments at the time of enrollment (baseline), start of treatment (if starting 60 days after enrollment), 4 weeks after the start of treatment, and every 2 months from the first HBOT treatment for 1 year. A subjective questionnaire regarding patient satisfaction will also be completed after the last HBOT treatment session and at 1 year after the start of treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Officially diagnosed with post COVID-19 condition by a healthcare practitioner\n3. At least three months since SARS-CoV-2 infection\n4. Symptoms that persist more than 12 weeks:\n\n * Chronic fatigue (must include) along with one of the following symptoms:\n * Difficulty thinking or problem solving ('brain fog')\n * Stress or anxiety\n\nExclusion Criteria:\n\n1. Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease)\n2. Patients with cognitive difficulties and/or mental retardation before COVID diagnosis\n3. History of traumatic brain injury\n4. Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)\n5. Known pregnancy or planning a pregnancy in women of childbearing age"}, 'identificationModule': {'nctId': 'NCT06082518', 'acronym': 'PCS-HBOT', 'briefTitle': 'Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments (PCS-HBOT Study)', 'orgStudyIdInfo': {'id': '5825'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate start of hyperbaric treatments', 'description': 'HBOT treatments will be scheduled to start immediately after referral.', 'interventionNames': ['Device: Monoplace Hyperbaric Chamber (Class III medical device).']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed start of hyperbaric treatments', 'description': 'HBOT treatments will be scheduled to start 60 days after referral.', 'interventionNames': ['Device: Monoplace Hyperbaric Chamber (Class III medical device).']}], 'interventions': [{'name': 'Monoplace Hyperbaric Chamber (Class III medical device).', 'type': 'DEVICE', 'description': '40 hyperbaric oxygen therapy (HBOT) treatments (90 minute exposures at 2 atmospheres (ATM) per treatment), scheduled daily from Monday to Friday (i.e., 5 treatments per week) until treatments are completed (approximately 8 weeks). Treatments will be delivered in a medical grade, Health Canada-approved monoplace hyperbaric chamber and overseen by specialist hyperbaric physicians and a Certified Hyperbaric Technologist.\n\nDevice is being used in manner consistent with approved usage in Canada.', 'armGroupLabels': ['Delayed start of hyperbaric treatments', 'Immediate start of hyperbaric treatments']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Fahad Alam, MD', 'role': 'CONTACT', 'email': 'fahad.alam@sunnybrook.ca', 'phone': '416-480-4864'}, {'name': 'Jordan Tarshis, MD,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Oskar Singer, MD,FRCPC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephen Choi, MD,FRCPC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peter Giacobbe, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stanley Hamstra, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adrienne Chan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Fahad Alam, MD', 'role': 'CONTACT', 'email': 'fahad.alam@sunnybrook.ca', 'phone': '416-480-4864'}, {'name': 'Lilia Kaustov, PhD', 'role': 'CONTACT', 'email': 'lilia.kaustov@sunnybrook.ca', 'phone': '416 480-6100', 'phoneExt': '89607'}], 'overallOfficials': [{'name': 'Fahad Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}, {'name': 'Jordan Tarshis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Upon publication, no limit on time.', 'ipdSharing': 'YES', 'description': 'De-identified data will be available upon request to study PIs following publication.', 'accessCriteria': 'Contact directly study principal investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}