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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

Tracking Information
First Submitted Date  ICMJE July 31, 2020
First Posted Date  ICMJE August 5, 2020
Last Update Posted Date November 1, 2021
Actual Study Start Date  ICMJE April 15, 2021
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Length of hospital stay [ Time Frame: Duration of study (to Day 28) ]
    Measured in days
  • Days with oxygen supplementation [ Time Frame: Duration of study (to Day 28) ]
    Number of days with oxygen supplementation
  • Daily oxygen flow values required to obtain saturation values ≥90%, [ Time Frame: Duration of study (to Day 28) ]
    Measured in L/min
  • ICU admission [ Time Frame: Duration of study (to Day 28) ]
    Yes/No
  • ICU length of stay [ Time Frame: Duration of study (to Day 28) ]
    Measured in days, if applicable
  • Days on invasive mechanical ventilation or high flow oxygenation [ Time Frame: Duration of study (to Day 28) ]
    Number of days on ventilator
  • Major arterial and venous thrombotic events [ Time Frame: Duration of study (to Day 28) ]
    e.g. stroke, pulmonary embolism, deep vein thrombosis
  • 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
  • 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.
  • 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.
  • Mortality [ Time Frame: Duration of study (to Day 28) ]
    Number of deaths
  • Incidence of any adverse events related to HBOT [ Time Frame: Duration of study (to Day 28) ]
    Number of adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
  • Length of hospital stay [ Time Frame: Duration of study (to Day 28) ]
    Measured in days
  • Days with oxygen supplementation [ Time Frame: Duration of study (to Day 28) ]
    Number of days with oxygen supplementation
  • Daily oxygen flow values required to obtain saturation values ≥90%, [ Time Frame: Duration of study (to Day 28) ]
    Measured in L/min
  • ICU admission [ Time Frame: Duration of study (to Day 28) ]
    Yes/No
  • ICU length of stay [ Time Frame: Duration of study (to Day 28) ]
    Measured in days, if applicable
  • Days on invasive mechanical ventilation or high flow oxygenation [ Time Frame: Duration of study (to Day 28) ]
    Number of days on ventilator
  • Major arterial and venous thrombotic events [ Time Frame: Duration of study (to Day 28) ]
    e.g. stroke, pulmonary embolism, deep vein thrombosis
  • 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
  • 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.
  • 7-level COVID ordinal outcome scale [ Time Frame: Measured on Day 28 ]
    Same scale as the primary outcome; different timing as a secondary outcome
  • Mortality [ Time Frame: Duration of study (to Day 28) ]
    Number of deaths
  • Safety events [ Time Frame: Duration of study (to Day 28) ]
    Incidence of any adverse events related to HBOT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
Official Title  ICMJE Multicentre Randomized Controlled Trial of Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE Drug: Oxygen
Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Oxygen
  • No Intervention: Control
    These patients will receive usual treatment for COVID-19, including oxygenation at normal atmospheric pressure (normobaric oxygenation).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2020)
234
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04500626
Other Study ID Numbers  ICMJE OHRI-HBOT-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ottawa Hospital Research Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ottawa Hospital Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Climate Foundation
Investigators  ICMJE
Principal Investigator: Sylvain Boet, MD, PhD The Ottawa Hospital
PRS Account Ottawa Hospital Research Institute
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP