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

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ClinicalTrials.gov Identifier: NCT04619719
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Enoch Huang, Legacy Health System

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.

Condition or disease Intervention/treatment Phase
Covid19 Device: Hyperbaric Oxygen Therapy (HBOT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center, Randomized Control Trial to Study the Effectiveness of Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Hyperbaric Oxygen
Hyperbaric Oxygen Therapy (HBOT) + Standard of Care (SOC) as defined by current best practice treatments for COVID-19
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.

No Intervention: Standard of Care
Standard of Care (SOC) as defined by current best practice treatments for COVID-19



Primary Outcome Measures :
  1. Incidence of 60-Day Patient Mortality [ Time Frame: 60 days ]
    Patient mortality is defined as death from any cause at 60 days after enrollment in the study


Secondary Outcome Measures :
  1. Time to Mechanical Ventilation [ Time Frame: Duration of inpatient hospitalization, approximately 2 to 4 weeks ]
  2. Number of Patients with Ongoing Clinical Symptoms [ Time Frame: 60 days ]
    Study participants will be asked about persistent symptoms at 60 days after hospitalization for COVID-19 (i.e., fatigue, dyspnea, joint pain, etc.)

  3. Number of Participants Displaying Presence of Any Pulmonary Function Abnormality [ Time Frame: 6 months ]
    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)).

  4. Number of Participants Displaying Presence of Any Pulmonary Function Abnormality [ Time Frame: 12 months ]
    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)).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04619719


Contacts
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Contact: Enoch Huang, MD 503-413-5355 enhuang@lhs.org
Contact: David Lee, MD 212-562-6561 David.Lee@nyulangone.org

Locations
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United States, Connecticut
Greenwich Hospital - Yale New Haven Health Recruiting
Greenwich, Connecticut, United States, 06830
Contact: Sandra Wainwright, MD       sandra.wainwright@greenwichhospital.org   
United States, Montana
Bozeman Health Recruiting
Bozeman, Montana, United States, 59715
Contact: Jessica Hoge, MD       jhoge@bozemanhealth.org   
United States, New York
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Scott Gorenstein, MD       Scott.gorenstein@nyulangone.org   
Principal Investigator: David Lee, MD         
Principal Investigator: Scott Gorenstein, MD         
United States, Oregon
Legacy Emanuel Medical Center Recruiting
Portland, Oregon, United States, 97227
Contact: Enoch Huang, MD       enhuang@lhs.org   
Principal Investigator: Enoch Huang, MD         
Principal Investigator: Davut Savaser, MD, MPH         
Sponsors and Collaborators
Legacy Health System
Investigators
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Principal Investigator: Enoch Huang, MD Legacy Research Institute
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Responsible Party: Enoch Huang, Principal Investigator, Legacy Health System
ClinicalTrials.gov Identifier: NCT04619719    
Other Study ID Numbers: 20-00897
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Enoch Huang, Legacy Health System:
Hyperbaric Oxygen
Additional relevant MeSH terms:
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COVID-19
Hypoxia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory