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Hyperbaric Oxygen for COVID-19 Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332081
Recruitment Status : Terminated (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.)
First Posted : April 2, 2020
Results First Posted : June 22, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE March 30, 2020
First Posted Date  ICMJE April 2, 2020
Results First Submitted Date  ICMJE June 14, 2021
Results First Posted Date  ICMJE June 22, 2021
Last Update Posted Date June 22, 2021
Actual Study Start Date  ICMJE April 6, 2020
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
Mortality [ Time Frame: through study completion; an average of 50 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
Mortality [ Time Frame: duration of hospitalization: 5-7 days on average ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
Need for Mechanical Ventilation [ Time Frame: through study completion; an average of 50 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
Days on invasive mechanical ventilation [ Time Frame: duration of hospitalization: 5-7 days on average ]
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
Official Title  ICMJE Open Label Single-Center Study of Emergency Hyperbaric Oxygen for Respiratory Distress in Patients With COVID-19
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
prospective pilot cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Device: hyperbaric oxygen therapy (HBOT)
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.
Study Arms  ICMJE
  • Experimental: Hyperbaric oxygen therapy (HBOT)
    Intervention: Device: hyperbaric oxygen therapy (HBOT)
  • No Intervention: Standard of Care
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 14, 2021)
80
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
40
Actual Study Completion Date  ICMJE May 29, 2020
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Male or female, age > 18 years
  2. Positive COVID 19 test
  3. Respiratory compromise defined by SpO2 <93%
  4. Ability to sign informed consent

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Pregnancy
  2. Untreated Pneumothorax
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04332081
Other Study ID Numbers  ICMJE 20-00399
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
Product Manufactured in and Exported from the U.S.: 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 made available immediately following publication, upon reasonable request by an investigator who proposes to use the data.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Immediately following publication. No end date.
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.
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NYU Langone Health
Verification Date June 2021

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