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Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia

Primary Purpose

Covid19

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hyperbaric Oxygen Therapy (HBOT)

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Hyperbaric Oxygen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years
Positive COVID 19 test or clear clinical diagnosis of COVID-19. Positive COVID-19 test will be confirmed based on a PCR or antigen test result or patient reported history. Clear clinical diagnosis of COVID-19 will be a combination of respiratory symptoms and clinical findings based on laboratory values and radiographs.
Moderate to severe hypoxemia defined by a baseline supplemental oxygen requirement of 6 liters or higher (including high flow oxygenation devices) as measured within the 24 hours before enrollment

Exclusion Criteria:

Pregnancy
Untreated pneumothorax, which must be evaluated with a baseline chest radiograph or computerized tomography scan at least 72 hours prior to enrollment
Presence of pneumomediastinum, pneumopericardium, significant subcutaneous emphysema, or pulmonary blebs, which should also be evaluated with a baseline chest radiograph prior to enrollment
Current invasive mechanical ventilation
Current non-invasive mechanical ventilation
Any patient who will not be stable for transport to the hyperbaric chamber, in addition to any relative contraindications identified by the treating hyperbaric physician or inpatient hospital team (e.g., severely impaired cardiac output due to significant myocardial injury).
Any patient without the capacity to provide informed consent

Sites / Locations

Bozeman Health
NYU Winthrop Hospital
Legacy Emanuel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hyperbaric Oxygen

Standard of Care

Arm Description

Hyperbaric Oxygen Therapy (HBOT) + Standard of Care (SOC) as defined by current best practice treatments for COVID-19

Standard of Care (SOC) as defined by current best practice treatments for COVID-19

Outcomes

Primary Outcome Measures

Incidence of 60-Day Patient Mortality

Patient mortality is defined as death from any cause at 60 days after enrollment in the study

Secondary Outcome Measures

Time to Mechanical Ventilation

Number of Patients with Ongoing Clinical Symptoms

Study participants will be asked about persistent symptoms at 60 days after hospitalization for COVID-19 (i.e., fatigue, dyspnea, joint pain, etc.)

Number of Participants Displaying Presence of Any Pulmonary Function Abnormality

Measured by spirometry and other lung tests (forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, diffusing capacity of the lung for carbon monoxide (DLCO)).

Number of Participants Displaying Presence of Any Pulmonary Function Abnormality

Measured by spirometry and other lung tests (forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, diffusing capacity of the lung for carbon monoxide (DLCO)).

Full Information

NCT ID

NCT04619719

First Posted

November 5, 2020

Last Updated

March 7, 2023

Sponsor

Legacy Health System

1. Study Identification

Unique Protocol Identification Number

NCT04619719

Brief Title

Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia

Official Title

Multi-Center, Randomized Control Trial to Study the Effectiveness of Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

Lack of patients

Study Start Date

March 15, 2021 (Actual)

Primary Completion Date

January 27, 2022 (Actual)

Study Completion Date

February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Legacy Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Of the many treatments proposed for COVID-19, few directly address the severe hypoxia among COVID-19 patients. Interim results from our single-center, non-randomized clinical trial (NCT04332081) suggest that hyperbaric oxygen therapy may reduce inpatient mortality or the need for mechanical ventilation among COVID-19 patients by more than half. Hyperbaric oxygen therapy is delivered by increasing the atmospheric pressure surrounding a patient, which results in increased oxygen delivery to a patient's blood at a rate higher than any other available modality. It is already FDA-approved for several indications, including conditions with impaired gas exchange and severe infectious processes. Furthermore, several studies have found that hyperbaric oxygen therapy inhibits the production of proinflammatory cytokines, which may play a role in the pathophysiology of COVID-19. The goal of this proposal is to perform a multi-center, randomized controlled trial to evaluate the short-term and long-term efficacy of hyperbaric oxygen therapy for COVID-19 patients. This proposal will rigorously test whether hyperbaric oxygen therapy can reduce the substantial mortality and morbidity of this challenging disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

Hyperbaric Oxygen

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hyperbaric Oxygen

Arm Type

Experimental

Arm Description

Hyperbaric Oxygen Therapy (HBOT) + Standard of Care (SOC) as defined by current best practice treatments for COVID-19

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Standard of Care (SOC) as defined by current best practice treatments for COVID-19

Intervention Type

Device

Intervention Name(s)

Hyperbaric Oxygen Therapy (HBOT)

Intervention Description

Patients assigned to the treatment arm will receive up to 5 treatments of hyperbaric oxygen therapy administered daily at 2.0 atmospheres for 90 minutes per session.

Primary Outcome Measure Information:

Title

Incidence of 60-Day Patient Mortality

Description

Patient mortality is defined as death from any cause at 60 days after enrollment in the study

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Time to Mechanical Ventilation

Time Frame

Duration of inpatient hospitalization, approximately 2 to 4 weeks

Title

Number of Patients with Ongoing Clinical Symptoms

Description

Study participants will be asked about persistent symptoms at 60 days after hospitalization for COVID-19 (i.e., fatigue, dyspnea, joint pain, etc.)

Time Frame

60 days

Title

Number of Participants Displaying Presence of Any Pulmonary Function Abnormality

Description

Measured by spirometry and other lung tests (forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, diffusing capacity of the lung for carbon monoxide (DLCO)).

Time Frame

6 months

Title

Number of Participants Displaying Presence of Any Pulmonary Function Abnormality

Description

Measured by spirometry and other lung tests (forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, diffusing capacity of the lung for carbon monoxide (DLCO)).

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years Positive COVID 19 test or clear clinical diagnosis of COVID-19. Positive COVID-19 test will be confirmed based on a PCR or antigen test result or patient reported history. Clear clinical diagnosis of COVID-19 will be a combination of respiratory symptoms and clinical findings based on laboratory values and radiographs. Moderate to severe hypoxemia defined by a baseline supplemental oxygen requirement of 6 liters or higher (including high flow oxygenation devices) as measured within the 24 hours before enrollment Exclusion Criteria: Pregnancy Untreated pneumothorax, which must be evaluated with a baseline chest radiograph or computerized tomography scan at least 72 hours prior to enrollment Presence of pneumomediastinum, pneumopericardium, significant subcutaneous emphysema, or pulmonary blebs, which should also be evaluated with a baseline chest radiograph prior to enrollment Current invasive mechanical ventilation Current non-invasive mechanical ventilation Any patient who will not be stable for transport to the hyperbaric chamber, in addition to any relative contraindications identified by the treating hyperbaric physician or inpatient hospital team (e.g., severely impaired cardiac output due to significant myocardial injury). Any patient without the capacity to provide informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enoch Huang, MD

Organizational Affiliation

Legacy Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bozeman Health

City

Bozeman

State/Province

Montana

ZIP/Postal Code

59715

Country

United States

Facility Name

NYU Winthrop Hospital

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Legacy Emanuel Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to David.Lee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia

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