Hyperbaric Oxygen for COVID-19 Patients

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04332081
• Other study ID #: 20-00399
• Status: Terminated
• Phase: N/A
• Start date: April 6, 2020
• Est. completion date: May 29, 2020

Study information

• Verified date: June 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: May 29, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Winthrop Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		through study completion; an average of 50 days
Secondary	Need for Mechanical Ventilation		through study completion; an average of 50 days