Compassionate Use of Hyperbaric Oxygen Therapy

October 21, 2020 updated by: SerenaGroup, Inc.

The Compassionate Use of Hyperbaric Oxygen Therapy in the Treatment of COVID-19

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-792
        • Klinika Baromedical
  • United States
    • Arkansas
      • Batesville, Arkansas, United States, 72501
        • White River Wound Healing Center
    • California
      • Monterey, California, United States, 93940
        • Community Hospital
    • Florida
      • Tampa, Florida, United States, 33614
        • Innovative Healing Systems
    • Indiana
      • Decatur, Indiana, United States, 47240
        • Decatur Memorial Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • Providence Medical Wound Care Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • West Jefferson Medical Center
      • Opelousas, Louisiana, United States, 70570
        • The Wound Treatment Center
      • Shreveport, Louisiana, United States, 71105
        • Christus Shreveport Bossier Hyperbaric & Wound Care Center
    • Michigan
      • Rochester, Michigan, United States, 48307
        • Ascension Providence Rochester Hospital Wound Care Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • CHI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with COVID-19.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SerenaGroup, Inc.

Collaborators

SerenaGroup Research Foundation

Investigators

  • Study Director: Thomas E Serena, MD, SerenaGroup, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Anticipated)

May 11, 2022

Study Completion (Anticipated)

May 11, 2022

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBOT-COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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