Hyperbaric Oxygen for COVID-19 Patients

NCT04332081 | Terminated Results DMC FDA Device

• 1 other identifier: 20-00399
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Mortality

  through study completion; an average of 50 days

Secondary Outcomes (1)

• Need for Mechanical Ventilation

  through study completion; an average of 50 days

Study Arms (2)

Hyperbaric oxygen therapy (HBOT)

EXPERIMENTAL

Device: hyperbaric oxygen therapy (HBOT)

Standard of Care

NO INTERVENTION

Interventions

hyperbaric oxygen therapy (HBOT) DEVICE

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.

Hyperbaric oxygen therapy (HBOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Results Point of Contact

• Title: David Lee
• Organization: NYU Langone

David.lee@nyulanogne.org

212-263-3293

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective pilot cohort study

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: April 6, 2020
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: June 22, 2021
• Results First Posted: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)