Covid19Phase 2/3NCT04500626
Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
A Phase 2/3 study testing Oxygen in people with Covid19, run by Ottawa Hospital Research Institute at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Apr 2021to Aug 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Not yet recruiting
The Ottawa Hospital
Ottawa, Ontario, K1Y4E9
Sylvain Boet, MD, PhD, 6137985555 ext. 78187, sboet@toh.on.ca
Joseph Burns, MSc, 613-798-5555 ext. 14775, josburns@ohri.ca
- Recruiting
Rouge Valley Hyperbaric Medical Centre
Scarborough Village, Ontario, M1E 5E9
Rita Katznelson, MD, rita.katznelson@uhn.ca
Research Coordinator, research@centenarypainclinic.ca
About this study
Official title: Multicentre Randomized Controlled Trial of Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
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.
Read more
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
- Being tested
- Oxygen
- Keywords
- Hyperbaric oxygen therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oxygen |
| Control | No intervention | These patients will receive usual treatment for COVID-19, including oxygenation at normal atmospheric pressure (normobaric oxygenation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured on Day 7
Secondary outcomes (12)
Length of hospital stay
Measured in days
Measured: Duration of study (to Day 28)
Days with oxygen supplementation
Number of days with oxygen supplementation
Measured: Duration of study (to Day 28)
Daily oxygen flow values required to obtain saturation values ≥90%,
Measured in L/min
Measured: Duration of study (to Day 28)
ICU admission
Yes/No
Measured: Duration of study (to Day 28)
ICU length of stay
Measured in days, if applicable
Measured: Duration of study (to Day 28)
Days on invasive mechanical ventilation or high flow oxygenation
Number of days on ventilator
Measured: Duration of study (to Day 28)
Major arterial and venous thrombotic events
e.g. stroke, pulmonary embolism, deep vein thrombosis
Measured: Duration of study (to Day 28)
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
Measured: Duration of study (to Day 28)
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.
Measured: Duration of study (to Day 28)
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: Measured on Day 28
Mortality
Number of deaths
Measured: Duration of study (to Day 28)
Incidence of any adverse events related to HBOT
Number of adverse events
Measured: Duration of study (to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start15 Apr 2021
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Climate Foundation
- Responsible party
- Sponsor
- Investigators
- Sylvain Boet, MD, PhD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500626
- Sponsor's protocol ID
- OHRI-HBOT-001
- Status last verified
- Oct 2021
- First submitted
- 31 Jul 2020
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Controlled Trial of Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04500626
- Acronym / sponsor ID
- OHRI-HBOT-001
- Conditions
- Covid19
- Keywords
- Hyperbaric oxygen therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Climate Foundation
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBOT | Experimental | Drug: OxygenThese 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. |
| Control | No intervention | –These patients will receive usual treatment for COVID-19, including oxygenation at normal atmospheric pressure (normobaric oxygenation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenHyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator. | Drug | HBOT |
Primary outcome
7-level COVID Ordinal Outcome Scale
Time frame: Measured on Day 7
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.
12 secondary outcomes
Length of hospital stay
Time frame: Duration of study (to Day 28)
Days with oxygen supplementation
Time frame: Duration of study (to Day 28)
Daily oxygen flow values required to obtain saturation values ≥90%,
Time frame: Duration of study (to Day 28)
ICU admission
Time frame: Duration of study (to Day 28)
ICU length of stay
Time frame: Duration of study (to Day 28)
Days on invasive mechanical ventilation or high flow oxygenation
Time frame: Duration of study (to Day 28)
Major arterial and venous thrombotic events
Time frame: Duration of study (to Day 28)
Sleep quality
Time frame: Duration of study (to Day 28)
Fatigue
Time frame: Duration of study (to Day 28)
7-level COVID Ordinal Outcome Scale
Time frame: Measured on Day 28
Mortality
Time frame: Duration of study (to Day 28)
Incidence of any adverse events related to HBOT
Time frame: Duration of study (to Day 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Preprint of study protocol (brief version for publication)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Boet, MD, PhD principal investigator
The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxygen in people with Covid19, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvain Boet, MD, PhD (613-737-8899 ext. 78187, sboet@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-level COVID Ordinal Outcome Scale (time frame: Measured on Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.