Hyperbaric Oxygen for COVID-19 Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open Label Single-Center Study of Emergency Hyperbaric Oxygen for Respiratory Distress in Patients With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Device: hyperbaric oxygen therapy (HBOT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: prospective pilot cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric oxygen therapy (HBOT)<br> | Device: hyperbaric oxygen therapy (HBOT)<br>* 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.<br>|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | through study completion; an average of 50 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Mechanical Ventilation |  | through study completion; an average of 50 days |