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

Sponsor

Ochsner Health System (Other)

Overall Status

Unknown status

CT.gov ID

NCT04343183

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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.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

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

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

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

Primary Outcome Measures

Decrease incidence of intubation by 30% or greater [one month]
Compare rates of intubation between treatment and control groups

Secondary Outcome Measures

Decrease renal injury [one month]
Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Ochsner Medical Center	New Orleans	Louisiana	United States	70121

Sponsors and Collaborators

Ochsner Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

John Engle, Medical Doctor, Ochsner Health System

ClinicalTrials.gov Identifier:

NCT04343183

Other Study ID Numbers:

STUDY00001051

First Posted:

Apr 13, 2020

Last Update Posted:

Apr 13, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by John Engle, Medical Doctor, Ochsner Health System

covid-19

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 13, 2020