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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Device: Hyperbaric Oxygen Therapy (HBOT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric Oxygen<br>Hyperbaric Oxygen Therapy (HBOT) + Standard of Care (SOC) as defined by current best practice treatments for COVID-19 | Device: Hyperbaric Oxygen Therapy (HBOT)<br>* 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.<br>|
| No Intervention: Standard of Care<br>Standard of Care (SOC) as defined by current best practice treatments for COVID-19 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of 60-Day Patient Mortality | Patient mortality is defined as death from any cause at 60 days after enrollment in the study | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Mechanical Ventilation |  | Duration of inpatient hospitalization, approximately 2 to 4 weeks | 
| 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.) | 60 days | 
| 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)). | 6 months | 
| 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)). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperbaric Oxygen