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Compassionate Use of Hyperbaric Oxygen Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386265
Recruitment Status : Unknown
Verified October 2020 by SerenaGroup, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : May 13, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
SerenaGroup Research Foundation
Information provided by (Responsible Party):
SerenaGroup, Inc.

Study Description
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Brief Summary:
This is an observational patient registry of COVID-19 patients treated with HBOT.

Condition or disease
COVID-19

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Compassionate Use of Hyperbaric Oxygen Therapy in the Treatment of COVID-19
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : May 11, 2022
Estimated Study Completion Date : May 11, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Gather information on adverse events [ Time Frame: 24 months ]
    Follow adverse events associated with the treatment of COVID-19 related to HBOT


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with COVID-19.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386265


Locations
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United States, Arkansas
White River Wound Healing Center
Batesville, Arkansas, United States, 72501
United States, California
Community Hospital
Monterey, California, United States, 93940
United States, Florida
Innovative Healing Systems
Tampa, Florida, United States, 33614
United States, Indiana
Decatur Memorial Hospital
Decatur, Indiana, United States, 47240
United States, Kansas
Providence Medical Wound Care Center
Kansas City, Kansas, United States, 66112
United States, Louisiana
West Jefferson Medical Center
Marrero, Louisiana, United States, 70072
The Wound Treatment Center
Opelousas, Louisiana, United States, 70570
Christus Shreveport Bossier Hyperbaric & Wound Care Center
Shreveport, Louisiana, United States, 71105
United States, Michigan
Ascension Providence Rochester Hospital Wound Care Center
Rochester, Michigan, United States, 48307
United States, Tennessee
CHI
Chattanooga, Tennessee, United States, 37404
Poland
Klinika Baromedical
Poznan, Wielkopolskie, Poland, 60-792
Sponsors and Collaborators
SerenaGroup, Inc.
SerenaGroup Research Foundation
Investigators
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Study Director: Thomas E Serena, MD SerenaGroup, Inc.
More Information
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Responsible Party: SerenaGroup, Inc.
ClinicalTrials.gov Identifier: NCT04386265    
Other Study ID Numbers: HBOT-COVID-19
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SerenaGroup, Inc.:
COVID-19
Mechanical Ventilation
Hyperbaric Oxygen Therapy
Patient Registry
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases