Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID... | NCT04343183

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

NCT04343183

Sponsor

Ochsner Health System

Status

Withdrawn

Last Update Posted

Apr 12, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

COVID-19

Interventions

Hyperbaric Oxygen Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Did not receive IRB approval

Expanded Access Info

Start Date

Apr 2020Estimated

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Apr 7, 2020

First Submission Date that Met QC Criteria

Apr 10, 2020

First Posted Date

Apr 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2023

Last Update Posted Date

Apr 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperbaric Oxygen Therapy	Device	Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.	HBOT treatment group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffery S Kuo, MD	Ochsner Health System	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ochsner Medical Center		New Orleans	Louisiana	70121	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Participants will be given a unique unidentifiable study ID number and all data will be recorded accorded to unidentifiable number to protect the patients personal health information.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006931	Hyperbaric Oxygenation

Ancestor Terms

ID	Term
D010102	Oxygen Inhalation Therapy
D012138	Respiratory Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided