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
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|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|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|
- 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.
- Gather information on adverse events [ Time Frame: 24 months ]Follow adverse events associated with the treatment of COVID-19 related to HBOT
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Sampling Method:||Non-Probability Sample|
- 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.
- The Subject has other concurrent conditions that in the opinion of the Investigator may compromise patient safety.
- The patient has an untreated pneumothorax.
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
|United States, Arkansas|
|White River Wound Healing Center|
|Batesville, Arkansas, United States, 72501|
|United States, California|
|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|
|Chattanooga, Tennessee, United States, 37404|
|Poznan, Wielkopolskie, Poland, 60-792|
|Study Director:||Thomas E Serena, MD||SerenaGroup, Inc.|
|Responsible Party:||SerenaGroup, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 13, 2020 Key Record Dates|
|Last Update Posted:||October 23, 2020|
|Last Verified:||October 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Hyperbaric Oxygen Therapy
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases