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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04343183

Enrollment

Registered

2020-04-13

Start date

2020-04-30

Completion date

2020-06-30

Last updated

2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

covid-19

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.

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.

Interventions

DEVICEHyperbaric Oxygen Therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

The biostatistician and radiologist will not know which group received HBOT.

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Decrease incidence of intubation by 30% or greater	one month	Compare rates of intubation between treatment and control groups

Secondary

Measure	Time frame	Description
Decrease renal injury	one month	Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026