Clinical trial NCT04500626: Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
Official title: Multicentre Randomized Controlled Trial of Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Covid19
Keywords: Hyperbaric oxygen therapy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Climate Foundation
First posted: 2020-08-05
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 7-level COVID Ordinal Outcome Scale
timeFrame: Measured on Day 7
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Duration of study (to Day 28)
measure: Days with oxygen supplementation
timeFrame: Duration of study (to Day 28)
measure: Daily oxygen flow values required to obtain saturation values ≥90%,
timeFrame: Duration of study (to Day 28)
measure: ICU admission
timeFrame: Duration of study (to Day 28)
measure: ICU length of stay
timeFrame: Duration of study (to Day 28)
measure: Days on invasive mechanical ventilation or high flow oxygenation
timeFrame: Duration of study (to Day 28)
measure: Major arterial and venous thrombotic events
timeFrame: Duration of study (to Day 28)
measure: Sleep quality
timeFrame: Duration of study (to Day 28)
measure: Fatigue
timeFrame: Duration of study (to Day 28)
measure: 7-level COVID Ordinal Outcome Scale
timeFrame: Measured on Day 28
measure: Mortality
timeFrame: Duration of study (to Day 28)
measure: Incidence of any adverse events related to HBOT
timeFrame: Duration of study (to Day 28)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Scarborough
country: Canada
facility: Rouge Valley Hyperbaric Medical Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Sylvain Boet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: