Back to resultsHyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring covid-19
Eligibility Criteria
Inclusion Criteria:
- Adult inpatients >18 years old
- Positive PCR COVID-19 testing
- CT evidence of interstitial opacity
- Oxygen saturation <90% on room air
- pO2 = 55-70.
Exclusion Criteria:
- Increased oxygen requirements
- Hemodynamic instability (MAP<65)
- Bradycardia (HR<50)
- History of seizure disorder
- Pneumothorax
- GFR<30
- Hemodialysis
- Refractory anxiety/claustrophobia
- Current pregnancy
- Uncorrectable hypoglycemia
Sites / Locations
- Ochsner Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
HBOT treatment group
Standard of Care group
Arm Description
Patients will receive hyperbaric oxygen therapy
Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol
Outcomes
Primary Outcome Measures
Decrease incidence of intubation by 30% or greater
Compare rates of intubation between treatment and control groups
Secondary Outcome Measures
Decrease renal injury
Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04343183
Brief Title
Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
Official Title
Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Did not receive IRB approval
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ochsner Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
covid-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The biostatistician and radiologist will not know which group received HBOT.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HBOT treatment group
Arm Type
Active Comparator
Arm Description
Patients will receive hyperbaric oxygen therapy
Arm Title
Standard of Care group
Arm Type
No Intervention
Arm Description
Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol
Intervention Type
Device
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.
Primary Outcome Measure Information:
Title
Decrease incidence of intubation by 30% or greater
Description
Compare rates of intubation between treatment and control groups
Time Frame
one month
Secondary Outcome Measure Information:
Title
Decrease renal injury
Description
Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult inpatients >18 years old
Positive PCR COVID-19 testing
CT evidence of interstitial opacity
Oxygen saturation <90% on room air
pO2 = 55-70.
Exclusion Criteria:
Increased oxygen requirements
Hemodynamic instability (MAP<65)
Bradycardia (HR<50)
History of seizure disorder
Pneumothorax
GFR<30
Hemodialysis
Refractory anxiety/claustrophobia
Current pregnancy
Uncorrectable hypoglycemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery S Kuo, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Study Chair
Facility Information:
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
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