Clinical trial NCT04619719: 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
Overall status: TERMINATED
Phase: NA
Conditions: Covid19
Keywords: Hyperbaric Oxygen
Lead sponsor: Legacy Health System
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of 60-Day Patient Mortality
timeFrame: 60 days
Secondary outcomes:
measure: Time to Mechanical Ventilation
timeFrame: Duration of inpatient hospitalization, approximately 2 to 4 weeks
measure: Number of Patients with Ongoing Clinical Symptoms
timeFrame: 60 days
measure: Number of Participants Displaying Presence of Any Pulmonary Function Abnormality
timeFrame: 6 months
measure: Number of Participants Displaying Presence of Any Pulmonary Function Abnormality
timeFrame: 12 months
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Bozeman Health
state: Montana
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
city: Portland
country: United States
facility: Legacy Emanuel Medical Center
state: Oregon
Study officials:
affiliation: Legacy Research Institute
name: Enoch Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: