We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04343183
Recruitment Status : Unknown
Verified April 2020 by John Engle, Ochsner Health System.
Recruitment status was:  Not yet recruiting
First Posted : April 13, 2020
Last Update Posted : April 13, 2020
Information provided by (Responsible Party):
John Engle, Ochsner Health System

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.

Condition or disease Intervention/treatment Phase
COVID-19 Device: Hyperbaric Oxygen Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Official Title: Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: HBOT treatment group
Patients will receive hyperbaric oxygen therapy
Device: Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.

No Intervention: Standard of Care group
Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol

Primary Outcome Measures :
  1. Decrease incidence of intubation by 30% or greater [ Time Frame: one month ]
    Compare rates of intubation between treatment and control groups

Secondary Outcome Measures :
  1. Decrease renal injury [ Time Frame: one month ]
    Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343183

Layout table for location contacts
Contact: John F Engle, MD 985-768-8918 englemd94@gmail.com
Contact: Michael D Lindley, MD 504-957-3326 mdlindley@gmail.com

Layout table for location information
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
Layout table for investigator information
Study Chair: Jeffery S Kuo, MD Ochsner Health System
Layout table for additonal information
Responsible Party: John Engle, Medical Doctor, Ochsner Health System
ClinicalTrials.gov Identifier: NCT04343183    
Other Study ID Numbers: STUDY00001051
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
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.

Layout table for additional information
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
Keywords provided by John Engle, Ochsner Health System:
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases