Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
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
- COVID-19
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
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator HBOT treatment group |
Patients will receive hyperbaric oxygen therapy |
|
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- Withdrawn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.