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Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343183
Recruitment Status : Not yet recruiting
First Posted : April 13, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
John Engle, Ochsner Health System

Tracking Information
First Submitted Date  ICMJE April 7, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date April 13, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)		 Decrease incidence of intubation by 30% or greater [ Time Frame: one month ]
Compare rates of intubation between treatment and control groups
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)		 Decrease renal injury [ Time Frame: one month ]
Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
Official Title  ICMJE Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description:
The biostatistician and radiologist will not know which group received HBOT.
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Device: Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.
Study Arms  ICMJE
  • Active Comparator: HBOT treatment group
    Patients will receive hyperbaric oxygen therapy
    Intervention: Device: Hyperbaric Oxygen Therapy
  • No Intervention: Standard of Care group
    Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)		 48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John F Engle, MD 985-768-8918 englemd94@gmail.com
Contact: Michael D Lindley, MD 504-957-3326 mdlindley@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04343183
Other Study ID Numbers  ICMJE STUDY00001051
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party John Engle, Ochsner Health System
Study Sponsor  ICMJE Ochsner Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jeffery S Kuo, MD Ochsner Health System
PRS Account Ochsner Health System
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP