Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: Climate Foundation

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%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)