Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
The biostatistician and radiologist will not know which group received HBOT.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
HBOT treatment group
Patients will receive hyperbaric oxygen therapy
  • Device: Hyperbaric Oxygen Therapy
    Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.
No Intervention
Standard of Care group
Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol

Recruiting Locations

More Details

NCT ID
NCT04343183
Status
Withdrawn
Sponsor
Ochsner Health System

Detailed Description

After enrollment, patients will be randomized into treatment vs control group. Both populations will receive the same inpatient medical treatment. All patients in the treatment group will undergo hyperbaric oxygen therapy under the same treatment protocol. After completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.