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

O

Ochsner Health System

Status

Withdrawn

Conditions

COVID-19

Treatments

Device: Hyperbaric Oxygen Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04343183
STUDY00001051

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

HBOT treatment group
Active Comparator group
Description:
Patients will receive hyperbaric oxygen therapy
Treatment:
Device: Hyperbaric Oxygen Therapy
Standard of Care group
No Intervention group
Description:
Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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