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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04619719
• Other study ID #: 20-00897
• Status: Terminated
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: February 9, 2023

Study information

• Verified date: March 2023
• Source: Legacy Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: February 9, 2023
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Hypoxia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Bozeman Health	Bozeman	Montana
United States	NYU Winthrop Hospital	Mineola	New York
United States	Legacy Emanuel Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Legacy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Mechanical Ventilation		Duration of inpatient hospitalization, approximately 2 to 4 weeks
Secondary	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
Secondary	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
Secondary	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