Hyperbaric Oxygen for COVID-19 Patients

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

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Mortality [ Time Frame: through study completion; an average of 50 days ]

Secondary Outcome Measures :

1. Need for Mechanical Ventilation [ Time Frame: through study completion; an average of 50 days ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, New York

NYU Winthrop Hospital

Mineola, New York, United States, 11501

Sponsors and Collaborators

NYU Langone Health

  Study Documents (Full-Text)

Documents provided by NYU Langone Health:

Study Protocol and Statistical Analysis Plan  [PDF] April 15, 2020

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04332081
• Other Study ID Numbers: 20-00399
• First Posted: April 2, 2020
• Results First Posted: June 22, 2021
• Last Update Posted: June 22, 2021
• Last Verified: June 2021

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.

• 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

Additional relevant MeSH terms:

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