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NCT04343183 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04343183
Other study ID # STUDY00001051
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2020
Est. completion date June 2020

Study information
Verified date April 2023
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Ochsner Medical Center New Orleans Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decrease incidence of intubation by 30% or greater Compare rates of intubation between treatment and control groups one month
Secondary Decrease renal injury Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups one month
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