Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

Ottawa Hospital Research Institute

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Covid19

Treatments: Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT04500626

OHRI-HBOT-001

Details and patient eligibility

About

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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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234 participants in 2 patient groups

HBOT

Experimental group

Description:

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.

Treatment:

Drug: Oxygen

Control

No Intervention group

Description:

These patients will receive usual treatment for COVID-19, including oxygenation at normal atmospheric pressure (normobaric oxygenation).