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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
234
Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.
The Ottawa Hospital
Ottawa, Ontario, Canada
NOT_YET_RECRUITINGRouge Valley Hyperbaric Medical Centre
Scarborough Village, Ontario, Canada
RECRUITING7-level COVID Ordinal Outcome Scale
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.
Time frame: Measured on Day 7
Length of hospital stay
Measured in days
Time frame: Duration of study (to Day 28)
Days with oxygen supplementation
Number of days with oxygen supplementation
Time frame: Duration of study (to Day 28)
Daily oxygen flow values required to obtain saturation values ≥90%,
Measured in L/min
Time frame: Duration of study (to Day 28)
ICU admission
Yes/No
Time frame: Duration of study (to Day 28)
ICU length of stay
Measured in days, if applicable
Time frame: Duration of study (to Day 28)
Days on invasive mechanical ventilation or high flow oxygenation
Number of days on ventilator
Time frame: Duration of study (to Day 28)
Major arterial and venous thrombotic events
e.g. stroke, pulmonary embolism, deep vein thrombosis
Time frame: Duration of study (to Day 28)
Sleep quality
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
Time frame: Duration of study (to Day 28)
Fatigue
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.
Time frame: Duration of study (to Day 28)
7-level COVID Ordinal Outcome Scale
Same scale as the primary outcome; different timing as a secondary outcome. Range is 1-7. Higher number indicates better clinical outcome.
Time frame: Measured on Day 28
Mortality
Number of deaths
Time frame: Duration of study (to Day 28)
Incidence of any adverse events related to HBOT
Number of adverse events
Time frame: Duration of study (to Day 28)
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