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

NCT04619719 | Terminated DMC FDA Device

• 1 other identifier: 20-00897
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19

Keywords

Hyperbaric Oxygen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to Mechanical Ventilation

  Duration of inpatient hospitalization, approximately 2 to 4 weeks

• Number of Patients with Ongoing Clinical Symptoms

  60 days

• Number of Participants Displaying Presence of Any Pulmonary Function Abnormality

  6 months

• Number of Participants Displaying Presence of Any Pulmonary Function Abnormality

  12 months

Study Arms (2)

Hyperbaric Oxygen

EXPERIMENTAL

Hyperbaric Oxygen Therapy (HBOT) + Standard of Care (SOC) as defined by current best practice treatments for COVID-19

Device: Hyperbaric Oxygen Therapy (HBOT)

Standard of Care

NO INTERVENTION

Standard of Care (SOC) as defined by current best practice treatments for COVID-19

Interventions

Hyperbaric Oxygen Therapy (HBOT) DEVICE

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.

Hyperbaric Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Legacy Health System: lead

Study Sites (3)

Bozeman Health

Bozeman, Montana, 59715, United States

Location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

Legacy Emanuel Medical Center

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Enoch Huang, MD

  Legacy Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 6, 2020
• Study Start: March 15, 2021
• Primary Completion: January 27, 2022
• Study Completion: February 9, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (3)