Hyperbaric Oxygen for COVID-19 Patients

• Sponsor: NYU Langone Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04332081
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 45.9

Study Details

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)	N/A

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
• Actual Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: prospective pilot cohort studyprospective 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: Apr 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 [through study completion; an average of 50 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	NYU Winthrop Hospital	Mineola	New York	United States	11501

Sponsors and Collaborators

• NYU Langone Health

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 15, 2020

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04332081
• Other Study ID Numbers: 20-00399
• First Posted: Apr 2, 2020
• Last Update Posted: Jun 22, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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

Study Results

Participant Flow

Arm/Group Title	Hyperbaric Oxygen Therapy (HBOT)	Standard of Care
Arm/Group Description	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 HBOT
Period Title: Overall Study
STARTED	20	60
COMPLETED	20	60
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Hyperbaric Oxygen Therapy (HBOT)	Standard of Care	Total
Arm/Group Description	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 HBOT	Total of all reporting groups
Overall Participants	20	60	80
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	58	62	60
Sex: Female, Male (Count of Participants)
Female	2 10%	5 8.3%	7 8.8%
Male	18 90%	55 91.7%	73 91.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	20 100%	60 100%	80 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 5%	6 10%	7 8.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 15%	10 16.7%	13 16.3%
White	7 35%	16 26.7%	23 28.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	9 45%	28 46.7%	37 46.3%
Region of Enrollment (participants) [Number]
United States	20 100%	60 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Mortality
Time Frame	through study completion; an average of 50 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Oxygen Therapy (HBOT)	Standard of Care
Arm/Group Description	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 HBOT
Measure Participants	20	60
Number [% of participants]	10 50%	22 36.7%

2. Secondary Outcome

Title	Need for Mechanical Ventilation
Time Frame	through study completion; an average of 50 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Oxygen Therapy (HBOT)	Standard of Care
Arm/Group Description	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 HBOT
Measure Participants	20	60
Count of Participants [Participants]	2 10%	18 30%

Adverse Events

Time Frame	through study completion; an average of 50 days
Arm/Group Title	Hyperbaric Oxygen Therapy (HBOT)		Standard of Care
Arm/Group Description	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 HBOT
All Cause Mortality
	Hyperbaric Oxygen Therapy (HBOT)		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		13/60 (21.7%)
Serious Adverse Events
	Hyperbaric Oxygen Therapy (HBOT)		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		0/60 (0%)
Respiratory, thoracic and mediastinal disorders
Hypoxic Arrest	1/20 (5%)	1	0/60 (0%)	0
Other (Not Including Serious) Adverse Events
	Hyperbaric Oxygen Therapy (HBOT)		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.