Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04500626
• Other study ID #: OHRI-HBOT-001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 15, 2021
• Est. completion date: August 2022

Study information

• Verified date: October 2021
• Source: Ottawa Hospital Research Institute
• Contact: Sylvain Boet, MD, PhD
• Phone: 613-737-8899
• Email: sboet[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Rouge Valley Hyperbaric Medical Centre	Scarborough	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Climate Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-level COVID Ordinal Outcome Scale	7-level scale based on patient's current status and need for oxygenation, also ability to resume normal activities (at higher levels). Range is 1-7. Higher number indicates better clinical outcome.	Measured on Day 7
Secondary	Length of hospital stay	Measured in days	Duration of study (to Day 28)
Secondary	Days with oxygen supplementation	Number of days with oxygen supplementation	Duration of study (to Day 28)
Secondary	Daily oxygen flow values required to obtain saturation values =90%,	Measured in L/min	Duration of study (to Day 28)
Secondary	ICU admission	Yes/No	Duration of study (to Day 28)
Secondary	ICU length of stay	Measured in days, if applicable	Duration of study (to Day 28)
Secondary	Days on invasive mechanical ventilation or high flow oxygenation	Number of days on ventilator	Duration of study (to Day 28)
Secondary	Major arterial and venous thrombotic events	e.g. stroke, pulmonary embolism, deep vein thrombosis	Duration of study (to Day 28)
Secondary	Sleep quality	Sleep Quality Scale, measured from 0 to 10. Higher number indicates worse sleep quality: 0 = "best possible sleep", 10 = "worst possible sleep". Capelleri et. al; Health and Quality of Life Outcomes 2009: 7:54	Duration of study (to Day 28)
Secondary	Fatigue	Single-Item Fatigue Report Mark, measured from 1 to 10. Higher number indicates worse fatigue: 1 = "not at all", 10 = "extremely". van Hooff et al; J Occup Health 2007; 49:224-234.	Duration of study (to Day 28)
Secondary	7-level COVID Ordinal Outcome Scale	Same scale as the primary outcome; different timing as a secondary outcome. Range is 1-7. Higher number indicates better clinical outcome.	Measured on Day 28
Secondary	Mortality	Number of deaths	Duration of study (to Day 28)
Secondary	Incidence of any adverse events related to HBOT	Number of adverse events	Duration of study (to Day 28)

External Links

•   Preprint of study protocol (brief version for publication)