COVID-19NCT04343183
Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
A study testing Hyperbaric Oxygen Therapy in people with COVID-19, run by Ochsner Health System at 1 site in United States.
Trial summary
Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2020to Jun 2020
- Phase
- Interventional
- 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
- Adult inpatients >18 years old
- Positive PCR COVID-19 testing
- CT evidence of interstitial opacity
- Oxygen saturation <90% on room air
- pO2 = 55-70.
Who cannot join
- Increased oxygen requirements
- Hemodynamic instability (MAP<65)
- Bradycardia (HR<50)
- History of seizure disorder
- Pneumothorax
- GFR<30
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- Hemodialysis
- Refractory anxiety/claustrophobia
- Current pregnancy
- Uncorrectable hypoglycemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Medical Center
New Orleans, Louisiana, 70121
About this study
Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.
Read the detailed description
After enrollment, patients will be randomized into treatment vs control group. Both populations will receive the same inpatient medical treatment. All patients in the treatment group will undergo hyperbaric oxygen therapy under the same treatment protocol. After completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.
- Conditions
- COVID-19
- Being tested
- Hyperbaric Oxygen Therapy
- Keywords
- covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDevice
Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.
| Study group | Role | What they receive |
|---|---|---|
| HBOT treatment group | Active comparator | Patients will receive hyperbaric oxygen therapy Receives: Device: Hyperbaric Oxygen Therapy |
| Standard of Care group | No intervention | Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease incidence of intubation by 30% or greater
Compare rates of intubation between treatment and control groups
Measured: one month
Secondary outcomes (1)
Decrease renal injury
Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Did not receive IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will utilize a single-center sequential two-parallel-group (HBOT/Standard care) randomized controlled design with 2 looks to allow for early stop due to clear benefit/harm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffery S Kuo, MD, Study chair, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343183
- Sponsor's protocol ID
- STUDY00001051
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Participants will be given a unique unidentifiable study ID number and all data will be recorded accorded to unidentifiable number to protect the patients personal health information.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
- ClinicalTrials.gov ID
- NCT04343183
- Acronym / sponsor ID
- STUDY00001051
- Conditions
- COVID-19
- Keywords
- covid-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not receive IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 13 Apr 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.
Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.
Detailed description
After enrollment, patients will be randomized into treatment vs control group. Both populations will receive the same inpatient medical treatment. All patients in the treatment group will undergo hyperbaric oxygen therapy under the same treatment protocol. After completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will utilize a single-center sequential two-parallel-group (HBOT/Standard care) randomized controlled design with 2 looks to allow for early stop due to clear benefit/harm.
| Arm | Type | Receives |
|---|---|---|
| HBOT treatment group | Active comparator | Device: Hyperbaric Oxygen TherapyPatients will receive hyperbaric oxygen therapy |
| Standard of Care group | No intervention | –Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult inpatients >18 years old
- Positive PCR COVID-19 testing
- CT evidence of interstitial opacity
- Oxygen saturation <90% on room air
- pO2 = 55-70.
Key exclusion criteria (10 listed)
- Increased oxygen requirements
- Hemodynamic instability (MAP<65)
- Bradycardia (HR<50)
- History of seizure disorder
- Pneumothorax
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 |
|---|---|---|
| Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration. | Device | HBOT treatment group |
Primary outcome
Decrease incidence of intubation by 30% or greater
Time frame: one month
Compare rates of intubation between treatment and control groups
1 secondary outcome
Decrease renal injury
Time frame: one month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No. Participants will be given a unique unidentifiable study ID number and all data will be recorded accorded to unidentifiable number to protect the patients personal health information.
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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.
Jeffery S Kuo, MD study chair
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with COVID-19, run by Ochsner Health System at 1 site in United States.
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 10 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: withdrawn, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease incidence of intubation by 30% or greater (time frame: one month). 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 12 Apr 2023.