Recruiting
Phase 2
Phase 3

HBOT

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04500626

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oxygen

Study Details

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.

Conditions

Covid19

Study ID

NCT04500626

Start date

Apr 15, 2021

Status verified date

Oct, 2021

Completion date

Aug, 2022

Anticipated

Primary completion date

Aug, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

234 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HBOT

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.

no intervention: Control

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

Interventions

Oxygen

Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.

Primary outcome measure

  • 7-level COVID Ordinal Outcome Scale [ Time Frame: Measured on Day 7 ]

Central Contacts and Locations

Central contacts

Sylvain Boet, MD, PhD

613-737-8899sboet@toh.ca

Joseph Burns, MSc

613-798-5555josburns@ohri.ca

Locations

Rouge Valley Hyperbaric Medical Centre

Recruiting

Scarborough, Ontario, Canada, M1E 5E9

Contacts

Rita Katznelson, MD

rita.katznelson@uhn.ca

Research Coordinator

research@centenarypainclinic.ca

Principal Investigator:

Rita Katznelson, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Nov 1, 2021

Last verified

Oct, 2021

Keywords

  • Hyperbaric oxygen therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2021-11-01.