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

NCT ID: NCT04619719

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2023-02-09

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperbaric Oxygen

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

Group Type: EXPERIMENTAL

Hyperbaric Oxygen Therapy (HBOT)

Intervention Type: DEVICE

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.

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyperbaric Oxygen Therapy (HBOT)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age > 18 years

2. 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.

3. 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

1. Pregnancy

2. Untreated pneumothorax, which must be evaluated with a baseline chest radiograph or computerized tomography scan at least 72 hours prior to enrollment

3. Presence of pneumomediastinum, pneumopericardium, significant subcutaneous emphysema, or pulmonary blebs, which should also be evaluated with a baseline chest radiograph prior to enrollment

4. Current invasive mechanical ventilation

5. Current non-invasive mechanical ventilation

6. 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).

7. Any patient without the capacity to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Legacy Health System

OTHER

Sponsor Role: lead

Responsible Party

Enoch Huang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enoch Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Legacy Research Institute

Locations

Bozeman Health

Bozeman, Montana, United States

NYU Winthrop Hospital

Mineola, New York, United States

Legacy Emanuel Medical Center

Portland, Oregon, United States

Countries

United States

Other Identifiers

20-00897

Identifier Type: -

Identifier Source: org_study_id