NCT04500626

Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

Multicentre Randomized Controlled Trial of Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Oxygen	Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2020-08-05
• Last updated: 2021-11-01

Locations

2 sites across 1 country: Canada