Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
NCT ID: NCT04500626
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
234 participants
INTERVENTIONAL
2021-04-15
2022-08-31
Brief Summary
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The investigators aim to improve outcomes for COVID-19 patients by implementing hyperbaric oxygen therapy (HBOT). HBOT allows patients to breathe 100% oxygen in a special chamber at a pressure higher than sea level. It is approved by Health Canada for 14 conditions. HBOT is safe when administered by experienced teams.
There are two main causes of death in severe COVID-19 respiratory infections: (i) a decreased diffusion of oxygen from the lungs to the blood and (ii) an increased inflammatory response (also called a "cytokine storm"). HBOT leads to increased oxygen level in blood, has strong anti-inflammatory effects, and may destroy the virus responsible for COVID-19 disease. The initial experience with HBOT and COVID-19 from China, France and the United States is promising in that it prevents further worsening of the condition and need for intensive care.
The investigators propose to test the effectiveness of HBOT for COVID-19 patients who are admitted to hospital to receive extra oxygen. Using the most rigorous and innovative research methods, this Canadian-led international study will operate at 5 centers across 3 countries (Canada: Ottawa, Toronto, Edmonton; Switzerland: Geneva; UK: Rugby/London). The investigators anticipate that when treated by HBOT, COVID-19 patients needing extra oxygen to breathe will see significant health improvements as well as a decrease in complications, inflammation in the blood, need for invasive care, death, and cost of care.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HBOT
These patients will receive hyperbaric oxygen therapy (HBOT) in addition to usual treatment for COVID-19. HBOT sessions will be 75 minutes in length at a pressure of 2.0 ATA.
Oxygen
Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.
Control
These patients will receive usual treatment for COVID-19, including oxygenation at normal atmospheric pressure (normobaric oxygenation).
No interventions assigned to this group
Interventions
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Oxygen
Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Confirmed COVID-19 positive by RT-PCR or another validated method
* Diagnosed with pneumonia requiring 21%\<FIO2≤100% to maintain saturation by pulse oximetry (SpO2) ≥90%
* Able and willing to comply with study procedures and follow-up examinations contained within the written consent form
Exclusion Criteria
* Pregnancy, determined by a serum or urine test
* Hemodynamic instability requiring vasopressors
* Inability to maintain a sitting position during treatment
* Inability to effectively understand and communicate with the hyperbaric operator, or to give consent
* Inability to spontaneously equalize ears and refusal of myringotomies
* Contraindications to HBOT (e.g. pneumothorax)
18 Years
ALL
No
Sponsors
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Climate Foundation
UNKNOWN
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Sylvain Boet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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The Ottawa Hospital
Ottawa, Ontario, Canada
Rouge Valley Hyperbaric Medical Centre
Scarborough Village, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Sylvain Boet, MD, PhD
Role: primary
Joseph Burns, MSc
Role: backup
Rita Katznelson, MD
Role: primary
Research Coordinator
Role: backup
Related Links
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Preprint of study protocol (brief version for publication)
Other Identifiers
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OHRI-HBOT-001
Identifier Type: -
Identifier Source: org_study_id