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

April 10, 2023 updated by: Ochsner Health System
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Investigators

  • Study Chair: Jeffery S Kuo, MD, Ochsner Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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