Hyperbaric Oxygen for COVID-19 Patients

Not Applicable

Terminated

• Conditions: COVID-19
• Interventions: Device: hyperbaric oxygen therapy (HBOT)

• Registration Number: NCT04332081
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-04-06
• Primary Completion: 2020-05-29
• Study Completion: 2020-05-29
• Status Verified: 2021-06
• Results First Submitted: 2021-06-14
• Results First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-16
• Results First Posted: 2021-06-22
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

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

1. Pregnancy
2. Untreated Pneumothorax

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperbaric oxygen therapy (HBOT)	hyperbaric oxygen therapy (HBOT)	-

Primary Outcome Measures

Name	Time	Method
Mortality	through study completion; an average of 50 days

Secondary Outcome Measures

Name	Time	Method
Need for Mechanical Ventilation	through study completion; an average of 50 days

Trial Locations

Locations (1)

NYU Winthrop Hospital; 🇺🇸 Mineola, New York, United States