Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

NCT04500626 | Unknown Phase 2 DMC

• 1 other identifier: OHRI-HBOT-001
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

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

Keywords

Hyperbaric oxygen therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Length of hospital stay

  Duration of study (to Day 28)

• Days with oxygen supplementation

  Duration of study (to Day 28)

• Daily oxygen flow values required to obtain saturation values ≥90%,

  Duration of study (to Day 28)

• ICU admission

  Duration of study (to Day 28)

• ICU length of stay

  Duration of study (to Day 28)

Study Arms (2)

HBOT

EXPERIMENTAL

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.

Drug: Oxygen

Control

NO INTERVENTION

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

Interventions

Oxygen DRUG

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

HBOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Climate Foundation: collaborator

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, K1Y4E9, Canada

NOT YET RECRUITING

Rouge Valley Hyperbaric Medical Centre

Scarborough Village, Ontario, M1E 5E9, Canada

RECRUITING

Related Links

• Preprint of study protocol (brief version for publication)

MeSH Terms

Conditions

COVID-19

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Sylvain Boet, MD, PhD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain Boet, MD, PhD

CONTACT

613-737-8899; sboet@toh.ca

Joseph Burns, MSc

CONTACT

613-798-5555; josburns@ohri.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: April 15, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)