COVID-19NCT04386265
Compassionate Use of Hyperbaric Oxygen Therapy
An observational study of COVID-19, run by SerenaGroup, Inc. at 11 sites in 2 countries.
Trial summary
This is an observational patient registry of COVID-19 patients treated with HBOT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 100 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 15 Apr 2020to 11 May 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with COVID-19.
Who may be able to join
- 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.
Who cannot join
- The Subject has other concurrent conditions that in the opinion of the Investigator may compromise patient safety.
- The patient has an untreated pneumothorax.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
White River Wound Healing Center
Batesville, Arkansas, 72501
CHI
Chattanooga, Tennessee, 37404
Decatur Memorial Hospital
Decatur, Indiana, 47240
Providence Medical Wound Care Center
Kansas City, Kansas, 66112
West Jefferson Medical Center
Marrero, Louisiana, 70072
Community Hospital
Monterey, California, 93940
The Wound Treatment Center
Opelousas, Louisiana, 70570
Ascension Providence Rochester Hospital Wound Care Center
Rochester, Michigan, 48307
Christus Shreveport Bossier Hyperbaric & Wound Care Center
Shreveport, Louisiana, 71105
Innovative Healing Systems
Tampa, Florida, 33614
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Keywords
- COVID-19, Mechanical Ventilation, Hyperbaric Oxygen Therapy, Patient Registry
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Gather information on patients treated with hyperbaric oxygen therapy
Collect information on the reduction in need for mechanical ventilation in COVID-19 patients.
Measured: 24 months
Secondary outcomes (1)
Gather information on adverse events
Follow adverse events associated with the treatment of COVID-19 related to HBOT
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start15 Apr 2020
- Primary completion11 May 2022 (estimated)
- Study completion11 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- SerenaGroup Research Foundation
- Responsible party
- Sponsor
- Investigators
- Thomas E Serena, MD, Study director, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386265
- Sponsor's protocol ID
- HBOT-COVID-19
- Status last verified
- Oct 2020
- First submitted
- 11 May 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Compassionate Use of Hyperbaric Oxygen Therapy in the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04386265
- Acronym / sponsor ID
- HBOT-COVID-19
- Conditions
- COVID-19
- Keywords
- COVID-19, Mechanical Ventilation, Hyperbaric Oxygen Therapy, Patient Registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- SerenaGroup Research Foundation
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 11 May 2022 (estimated)
- Study completion
- 11 May 2022 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with COVID-19.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- The Subject has other concurrent conditions that in the opinion of the Investigator may compromise patient safety.
- The patient has an untreated pneumothorax.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Gather information on adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E Serena, MD study director
SerenaGroup, Inc.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by SerenaGroup, Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gather information on patients treated with hyperbaric oxygen therapy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.