Hyperbaric Oxygen for COVID-19 Patients
Primary Purpose
COVID-19
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hyperbaric oxygen therapy (HBOT)
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, age > 18 years
- Positive COVID 19 test
- Respiratory compromise defined by SpO2 <93%
- Ability to sign informed consent
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy
- Untreated Pneumothorax
Sites / Locations
- NYU Winthrop Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hyperbaric oxygen therapy (HBOT)
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Need for Mechanical Ventilation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04332081
Brief Title
Hyperbaric Oxygen for COVID-19 Patients
Official Title
Open Label Single-Center Study of Emergency Hyperbaric Oxygen for Respiratory Distress in Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
The IRB has determined that the design of this trial should be changed to a randomized controlled trial. A new record will be created for the redesigned study.
Study Start Date
April 6, 2020 (Actual)
Primary Completion Date
May 29, 2020 (Actual)
Study Completion Date
May 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hyperbaric oxygen therapy (HBOT) treatment will be provided to patients as an adjunct to standard therapy for a cohort of 40 COVID19-positive patients with respiratory distress at NYU Winthrop Hospital. All patients prior to the clinical application of HBOT will be evaluated by the primary care team and hyperbaric physician. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.
Detailed Description
This is a single center prospective pilot cohort study to evaluate the safety and efficacy of hyperbaric oxygen therapy (HBOT) as an emergency investigational device for treating patients with a novel coronavirus, disease, COVID-19. Patients that meet inclusion criteria will be consented by the hyperbaric physician. They will then be transported from the ED or other unit to the hyperbaric unit maintaining airborne precautions based on the most current hospital protocol. All study personnel will have proper PPE at all times. The patient will then be placed into the monoplace chamber and when the chamber door is closed the patient will remove any respiratory filter/mask that was placed. The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medical unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective pilot cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric oxygen therapy (HBOT)
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
hyperbaric oxygen therapy (HBOT)
Intervention Description
The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.
Primary Outcome Measure Information:
Title
Mortality
Time Frame
through study completion; an average of 50 days
Secondary Outcome Measure Information:
Title
Need for Mechanical Ventilation
Time Frame
through study completion; an average of 50 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Male or female, age > 18 years
Positive COVID 19 test
Respiratory compromise defined by SpO2 <93%
Ability to sign informed consent
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Pregnancy
Untreated Pneumothorax
Facility Information:
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be made available immediately following publication, upon reasonable request by an investigator who proposes to use the data.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Requests should be directed to David.Lee@nyulangone.org and Scott.Gorenstein@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Hyperbaric Oxygen for COVID-19 Patients
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