Compassionate Use of Hyperbaric Oxygen Therapy

• Conditions: COVID-19

• Registration Number: NCT04386265
• Lead Sponsor: SerenaGroup, Inc.

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.

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-13
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (11)

CHI; 🇺🇸 Chattanooga, Tennessee, United States

Providence Medical Wound Care Center; 🇺🇸 Kansas City, Kansas, United States

Innovative Healing Systems; 🇺🇸 Tampa, Florida, United States

Community Hospital; 🇺🇸 Monterey, California, United States

Decatur Memorial Hospital; 🇺🇸 Decatur, Indiana, United States

The Wound Treatment Center; 🇺🇸 Opelousas, Louisiana, United States

Klinika Baromedical; 🇵🇱 Poznan, Wielkopolskie, Poland

Christus Shreveport Bossier Hyperbaric & Wound Care Center; 🇺🇸 Shreveport, Louisiana, United States

Ascension Providence Rochester Hospital Wound Care Center; 🇺🇸 Rochester, Michigan, United States

White River Wound Healing Center; 🇺🇸 Batesville, Arkansas, United States

West Jefferson Medical Center; 🇺🇸 Marrero, Louisiana, United States