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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2020

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.

Interventions

  • Device: Hyperbaric Oxygen Therapy
    • Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Decrease incidence of intubation by 30% or greater
    • Time Frame: one month
    • Compare rates of intubation between treatment and control groups

Secondary Measures

  • Decrease renal injury
    • Time Frame: one month
    • Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ochsner Health System
  • Provider of Information About this Clinical Study
    • Principal Investigator: John Engle, Medical Doctor – Ochsner Health System
  • Overall Official(s)
    • Jeffery S Kuo, MD, Study Chair, Ochsner Health System
  • Overall Contact(s)
    • John F Engle, MD, 985-768-8918, englemd94@gmail.com

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