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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. 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
Sponsor:
Information provided by (Responsible Party):
John Engle, Ochsner Health System

Study Description
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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.
Study Design
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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


Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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


Contacts
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Contact: John F Engle, MD 985-768-8918 englemd94@gmail.com
Contact: Michael D Lindley, MD 504-957-3326 mdlindley@gmail.com

Locations
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United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
Investigators
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Study Chair: Jeffery S Kuo, MD Ochsner Health System
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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.

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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:
covid-19
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases