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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
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
COVID-19 Device: hyperbaric oxygen therapy (HBOT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: prospective pilot cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Single-Center Study of Emergency Hyperbaric Oxygen for Respiratory Distress in Patients With COVID-19
Actual Study Start Date : April 6, 2020
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : May 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Hyperbaric oxygen therapy (HBOT) 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.

No Intervention: Standard of Care



Primary Outcome Measures :
  1. Mortality [ Time Frame: duration of hospitalization: 5-7 days on average ]

Secondary Outcome Measures :
  1. Need for mechanical ventilation [ Time Frame: duration of hospitalization: 5-7 days on average ]
  2. Days on invasive mechanical ventilation [ Time Frame: duration of hospitalization: 5-7 days on average ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

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

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): NCT04332081


Locations
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United States, New York
NYU Winthrop Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04332081    
Other Study ID Numbers: s20-00399
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
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
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.

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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