Compassionate Use of Hyperbaric Oxygen Therapy | NCT04386265

Studies
Compassionate Use of Hyperbaric Oxygen Therapy

NCT04386265

Sponsor

SerenaGroup, Inc.

Status

Unknown status

Last Update Posted

Oct 23, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

United States
Poland

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2020Actual

Primary Completion Date

May 11, 2022Estimated

Completion Date

May 11, 2022Estimated

First Submitted Date

May 11, 2020

First Submission Date that Met QC Criteria

May 11, 2020

First Posted Date

May 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

Oct 21, 2020

Last Update Posted Date

Oct 23, 2020Actual

Name	Class
SerenaGroup Research Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational patient registry of COVID-19 patients treated with HBOT.

Detailed Description

The retrospective analysis will focus on the reduction in need for mechanical ventilation in COVID-19 patients. The information will be gathered prospectively. Data will be collected from the patients' medical record, including medical notes and data recorded into the study database.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gather information on patients treated with hyperbaric oxygen therapy	Collect information on the reduction in need for mechanical ventilation in COVID-19 patients.	24 months

Secondary Outcomes

Measure	Description	Time Frame
Gather information on adverse events	Follow adverse events associated with the treatment of COVID-19 related to HBOT	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with COVID-19.
The clinical decision to use HBOT is independent of the decision to participate in registry.
A signed and dated informed consent form for the off-label use of Hyperbaric Oxygen Therapy specific to the institution where treatment is rendered.
Subject is willing and able to comply with instructions and scheduled visits.

Exclusion Criteria:

The Subject has other concurrent conditions that in the opinion of the Investigator may compromise patient safety.
The patient has an untreated pneumothorax.

Accepts Healthy Volunteers

Not provided

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

Adult patients with COVID-19.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas E Serena, MD	SerenaGroup, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
White River Wound Healing Center		Batesville	Arkansas	72501	United States
Community Hospital

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