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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04619719
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Enoch Huang, Legacy Health System

Tracking Information
First Submitted Date  ICMJE November 5, 2020
First Posted Date  ICMJE November 6, 2020
Last Update Posted Date August 16, 2022
Actual Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
Time to Patient Mortality [ Time Frame: Duration of inpatient hospitalization, approximately 2 to 4 weeks ]
Patient mortality is defined as death from any cause during the hospitalization of study participants
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2021)
  • Time to Mechanical Ventilation [ Time Frame: Duration of inpatient hospitalization, approximately 2 to 4 weeks ]
  • 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.)
  • 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)).
  • 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)).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • Time to Mechanical Ventilation [ Time Frame: Duration of inpatient hospitalization, approximately 2 to 4 weeks ]
  • 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)).
  • 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)).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia
Official Title  ICMJE Multi-Center, Randomized Control Trial to Study the Effectiveness of Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Hyperbaric Oxygen
    Hyperbaric Oxygen Therapy (HBOT) + Standard of Care (SOC) as defined by current best practice treatments for COVID-19
    Intervention: Device: Hyperbaric Oxygen Therapy (HBOT)
  • No Intervention: Standard of Care
    Standard of Care (SOC) as defined by current best practice treatments for COVID-19
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2021)
360
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2020)
600
Estimated Study Completion Date  ICMJE June 15, 2023
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Enoch Huang, MD 503-413-5355 enhuang@lhs.org
Contact: David Lee, MD 212-562-6561 David.Lee@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04619719
Other Study ID Numbers  ICMJE 20-00897
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.
Current Responsible Party Enoch Huang, Legacy Health System
Original Responsible Party NYU Langone Health
Current Study Sponsor  ICMJE Legacy Health System
Original Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Enoch Huang, MD Legacy Research Institute
PRS Account Legacy Health System
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP