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Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04500626
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : November 1, 2021
Sponsor:
Collaborator:
Climate Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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Brief Summary:

At least 1 in 6 COVID-19 patients admitted to hospital to receive extra oxygen will die of complications. In patients with COVID-19, invasive treatment such as mechanical ventilation (e.g. breathing with a machine) is associated with a 50% increased risk of death. Invasive treatments use a lot of healthcare resources in intensive care units and may lead to further deaths if patients do not have access to care.

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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Oxygen Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre Randomized Controlled Trial of Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
Actual Study Start Date : April 15, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Oxygen
Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.
No Intervention: Control
These patients will receive usual treatment for COVID-19, including oxygenation at normal atmospheric pressure (normobaric oxygenation).


Outcome Measures
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Primary Outcome Measures :
  1. 7-level COVID Ordinal Outcome Scale [ Time Frame: Measured on Day 7 ]
    7-level scale based on patient's current status and need for oxygenation, also ability to resume normal activities (at higher levels). Range is 1-7. Higher number indicates better clinical outcome.


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Duration of study (to Day 28) ]
    Measured in days

  2. Days with oxygen supplementation [ Time Frame: Duration of study (to Day 28) ]
    Number of days with oxygen supplementation

  3. Daily oxygen flow values required to obtain saturation values ≥90%, [ Time Frame: Duration of study (to Day 28) ]
    Measured in L/min

  4. ICU admission [ Time Frame: Duration of study (to Day 28) ]
    Yes/No

  5. ICU length of stay [ Time Frame: Duration of study (to Day 28) ]
    Measured in days, if applicable

  6. Days on invasive mechanical ventilation or high flow oxygenation [ Time Frame: Duration of study (to Day 28) ]
    Number of days on ventilator

  7. Major arterial and venous thrombotic events [ Time Frame: Duration of study (to Day 28) ]
    e.g. stroke, pulmonary embolism, deep vein thrombosis

  8. Sleep quality [ Time Frame: Duration of study (to Day 28) ]
    Sleep Quality Scale, measured from 0 to 10. Higher number indicates worse sleep quality: 0 = "best possible sleep", 10 = "worst possible sleep". Capelleri et. al; Health and Quality of Life Outcomes 2009: 7:54

  9. Fatigue [ Time Frame: Duration of study (to Day 28) ]
    Single-Item Fatigue Report Mark, measured from 1 to 10. Higher number indicates worse fatigue: 1 = "not at all", 10 = "extremely". van Hooff et al; J Occup Health 2007; 49:224-234.

  10. 7-level COVID Ordinal Outcome Scale [ Time Frame: Measured on Day 28 ]
    Same scale as the primary outcome; different timing as a secondary outcome. Range is 1-7. Higher number indicates better clinical outcome.

  11. Mortality [ Time Frame: Duration of study (to Day 28) ]
    Number of deaths

  12. Incidence of any adverse events related to HBOT [ Time Frame: Duration of study (to Day 28) ]
    Number of adverse events


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant female patients
  • 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:

  • Patient clinical status felt to be incompatible with HBOT, e.g. respiratory failure requiring mechanical ventilation
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04500626


Contacts
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Contact: Sylvain Boet, MD, PhD 613-737-8899 ext 78187 sboet@toh.ca
Contact: Joseph Burns, MSc 613-798-5555 ext 14775 josburns@ohri.ca

Locations
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Canada, Ontario
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1Y4E9
Contact: Sylvain Boet, MD, PhD    6137985555 ext 78187    sboet@toh.on.ca   
Contact: Joseph Burns, MSc    613-798-5555 ext 14775    josburns@ohri.ca   
Rouge Valley Hyperbaric Medical Centre Recruiting
Scarborough, Ontario, Canada, M1E 5E9
Contact: Rita Katznelson, MD       rita.katznelson@uhn.ca   
Contact: Research Coordinator       research@centenarypainclinic.ca   
Principal Investigator: Rita Katznelson, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Climate Foundation
Investigators
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Principal Investigator: Sylvain Boet, MD, PhD The Ottawa Hospital
More Information
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Additional Information:

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04500626    
Other Study ID Numbers: OHRI-HBOT-001
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Hyperbaric oxygen therapy
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases