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NCT04386265 Clinical Trial

Compassionate Use of Hyperbaric Oxygen Therapy

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04386265
Other study ID # HBOT-COVID-19
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date May 11, 2022

Study information
Verified date October 2020
Source SerenaGroup, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date May 11, 2022
Est. primary completion date May 11, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Poland Klinika Baromedical Poznan Wielkopolskie
United States White River Wound Healing Center Batesville Arkansas
United States CHI Chattanooga Tennessee
United States Decatur Memorial Hospital Decatur Indiana
United States Providence Medical Wound Care Center Kansas City Kansas
United States West Jefferson Medical Center Marrero Louisiana
United States Community Hospital Monterey California
United States The Wound Treatment Center Opelousas Louisiana
United States Ascension Providence Rochester Hospital Wound Care Center Rochester Michigan
United States Christus Shreveport Bossier Hyperbaric & Wound Care Center Shreveport Louisiana
United States Innovative Healing Systems Tampa Florida

Sponsors (2)
Lead Sponsor Collaborator
SerenaGroup, Inc. SerenaGroup Research Foundation

Countries where clinical trial is conducted

United States,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Gather information on adverse events Follow adverse events associated with the treatment of COVID-19 related to HBOT 24 months
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