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Use of Hyperbaric Oxygen Therapy to Treat COVID-19 Patients With Respiratory Distress (HBOT)

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ClinicalTrials.gov Identifier: NCT04800120
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Jill Trelease, Steward St. Elizabeth's Medical Center of Boston, Inc.

Study Description
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Brief Summary:
Investigate whether hyperbaric oxygen therapy treatment can become a viable treatment option for COVID-19. If successful, providers will be able to provide future COVID-19 patients with mild-to-moderate respiratory distress hyperbaric oxygen therapy in order to help avoid mechanical ventilation

Condition or disease Intervention/treatment Phase
Covid19 Other: Hyperbaric Oxygen Therapy Not Applicable

Detailed Description:

Using the Monoplace Hyperbaric Oxygen Chambers we will be providing COVID- 19 positive patients with mild-to-moderate distress 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatments. A comparison will be made using a historical cohort not receiving HBOT. Data will be collected to determine whether or not HBOT is of any benefit to COVID-19 positive patient with mild-to-moderate respiratory distress.

Study Group: Provide 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatment to COVID-19 patients meeting inclusion criteria Control Group: Any COVID-19 positive patient meeting study inclusion criteria that does not receive HBOT (historical) The control group is further defined as patients who were previously treated for COVID-19 at Morton Hospital that did not receive hyperbaric oxygen therapy. This will require accessing medical records to obtain patient information to establish the historical control data metric.

Study outcome measures:

  • Time to normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)
  • Mortality
  • Days free of invasive mechanical ventilation
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Study Group: Provide 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatment to COVID-19 patients meeting inclusion criteria Control Group: Any COVID-19 positive patient meeting study inclusion criteria that does not receive HBOT (historical)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Hyperbaric Oxygen Therapy (HBOT) for the Treatment of COVID-19 Patients With Mild-to-moderate Respiratory Distress
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Study Group
Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy
 Other: Hyperbaric Oxygen Therapy
Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber
Other Name: HBOT
No Intervention: Control Group
Historical control of COVID 19 patients who were previously treated and did not receiving Hyperbaric Oxygen Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Normalization of oxygen [ Time Frame: through study completion, an average of 1 year ]
    normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)


Secondary Outcome Measures :
  1. Mortality [ Time Frame: through study completion, an average of 1 year ]
    Patient survival of COVID-19

  2. Days free of invasive mechanical ventilation [ Time Frame: through study completion, an average of 1 year ]
    The time which patient remains without the need for intubation


Eligibility Criteria
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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:

  • Verified COVID-19 infection
  • Patient w/02 dependence of less than or equal to 6 liter/min to maintain pulse ox greater than or equal to 92% or arterial gas w/PA02 greater than 60mm HG

Exclusion Criteria:

  • Not diagnosed w/COVID-19 infection
  • Pregnancy
  • DNR or other restrictions in escalation of level of care
  • Contraindication for HBO
  • Blood pressure parameters which are deemed unstable by clinical team
  • Patients who require continuous ECG and/or continuous blood pressure monitoring, and with arterial lines
  • Patients requiring rewarming
  • Patients requiring any kind of invasive catheter/pressure monitoring
  • Patients requiring continuous support of intravenous medication
  • Minor subject (less than 18 years old)
  • Refusal to participate
  • Signs of respiratory decompensation requiring intubation and mechanical ventilation
  • 02 dependence greater than or equal to 6L/minute to obtain Sa02 greater than or equal to 92% or ABG w/Pa02 >60mmHg
Contacts and Locations
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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): NCT04800120


Contacts
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Contact: Jill Trelease, DNP 508-828-7000 jill.trelease@steward.org

Locations
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United States, Massachusetts
Morton Hospital Recruiting
Taunton, Massachusetts, United States, 02780
Contact: Patricia Pfeiffer, MPH    508-828-7000 ext 7363    patricia.pfeiffer@steward.org   
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Investigators
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Principal Investigator: Jill Trelease, DNP Steward Healthcare
More Information
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Responsible Party: Jill Trelease, Program Director, Center for Wound Healing at Morton Hospital, Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT04800120    
Other Study ID Numbers: IRB Protocol #00800
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases