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

NCT ID: NCT04343183

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The biostatistician and radiologist will not know which group received HBOT.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HBOT treatment group

Patients will receive hyperbaric oxygen therapy

Group Type ACTIVE_COMPARATOR

Hyperbaric Oxygen Therapy

Intervention Type DEVICE

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

Standard of Care group

Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hyperbaric Oxygen Therapy

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ochsner Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffery S Kuo, MD

Role: STUDY_CHAIR

Ochsner Health System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00001051

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hyperbaric Oxygen in Lower Leg Trauma
NCT00264511 COMPLETED PHASE2/PHASE3
The VENTOR Clinical Study
NCT06759389 RECRUITING NA