Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection

NCT04343183 | Withdrawn FDA Device

• 1 other identifier: STUDY00001051
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.

Conditions

COVID-19

Keywords

covid-19

Outcome Measures

Primary Outcomes (1)

• Decrease incidence of intubation by 30% or greater

  Compare rates of intubation between treatment and control groups

  one month

Secondary Outcomes (1)

• Decrease renal injury

  one month

Study Arms (2)

HBOT treatment group

ACTIVE COMPARATOR

Patients will receive hyperbaric oxygen therapy

Device: Hyperbaric Oxygen Therapy

Standard of Care group

NO INTERVENTION

Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol

Interventions

Hyperbaric Oxygen Therapy DEVICE

Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.

HBOT treatment group

Eligibility Criteria

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

You may qualify if:

• Adult inpatients \>18 years old
• Positive PCR COVID-19 testing
• CT evidence of interstitial opacity
• Oxygen saturation \<90% on room air
• pO2 = 55-70.

You may not qualify if:

• Increased oxygen requirements
• Hemodynamic instability (MAP\<65)
• Bradycardia (HR\<50)
• History of seizure disorder
• Pneumothorax
• GFR\<30
• Hemodialysis
• Refractory anxiety/claustrophobia
• Current pregnancy
• Uncorrectable hypoglycemia

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, 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

Study Officials

• Jeffery S Kuo, MD

  Ochsner Health System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The biostatistician and radiologist will not know which group received HBOT.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will utilize a single-center sequential two-parallel-group (HBOT/Standard care) randomized controlled design with 2 looks to allow for early stop due to clear benefit/harm.

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 13, 2020
• Study Start: April 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)