PROJECT HIGHLIGHTS
Governance Organization
TOH – The Ottawa Hospital Academic Medical Organization
Project Title
TOH-21-015 – Multi-centre randomized controlled trial of hyperbaric oxygen therapy for COVID-19
Project Highlights
This project aimed to evaluate the effect of hyperbaric oxygen therapy (HBOT) on clinical outcome status in hypoxemic hospitalized COVID-19 patients. HBOT is the breathing of 100% oxygen in an elevated pressure environment, usually twice or more than that found at sea level. HBOT increases oxygen levels in the blood, reduces inflammation, and may directly attack the virus responsible for the COVID-19 disease. While initial case studies from China, the United States, and Russia showed promise that HBOT can reduce clinical deterioration and the need for intensive care among COVID-19 patients, a multicentre trial had yet to be conducted. We obtained a No Objection Letter from Health Canada on July 30, 2020. Ethics approval was obtained from Clinical Trials Ontario on August 7, 2020, Ottawa Health Sciences Network Research Ethics Board on January 28, 2021, and Scarborough Health Network Research Ethics Board on April 22, 2021. One of our hyperbaric chambers required a repair in January 2021 which delayed the start date of our recruitment by four months. Our trial began recruiting patients in Ottawa on April 15, 2021. After initiating the study, we amended the protocol to adjust multiple elements for feasibility reasons. These changes included eliminating unnecessary blood tests and limiting patients to 10 treatments instead of our initially planned 28, based on clinical experience. This allowed us to maximize the availability of hyperbaric chambers for new patients. Currently, we have recruited 38 patients from two sites (33 from Ottawa and 5 from Scarborough). Of these 38 patients, 58% (n=22) were under 60 years of age and 53% were male (n=20). Following randomization, 20 patients were randomized to the HBOT group, and 18 were randomized to the standard of care (control) group. The baseline clinical status of patients in each group was similar, with patients entering the trial hospitalized and on high flow oxygen therapy/non-invasive mechanical ventilation (HBOT group: n=7[35%]; Control group: n=8 [44%]) or hospitalized on supplemental oxygen (HBOT group: n=13 [65%]; Control group: n=10 [56%]). The 28-day follow-up period has been completed by 37 patients and one patient remains enrolled in the study. Early results suggest that patients treated with HBOT may have better outcomes at day 28 than patients who receive usual care. The average change in clinical status score between baseline and day 28 was 1.7 for the HBOT group and 1.5 for the control group. Recruitment is ongoing and we expect to recruit at least two more patients by the end of the year, for a total of 40 patients.
Theme
Prevention and Treatment
Primary Project Lead for Contact
Sylvain Boet