Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001428752p
Ethics application status
Not yet submitted
Date submitted
3/11/2022
Date registered
8/11/2022
Date last updated
8/11/2022
Date data sharing statement initially provided
8/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of utility of Hyperbaric Oxygen Treatment (HBOT) for Long-COVID syndrome
Scientific title
Investigation of utility of Hyperbaric Oxygen Treatment (HBOT) for Long-COVID syndrome
Secondary ID [1] 299570 0
nil known
Universal Trial Number (UTN)
U1111-1284-4363
Trial acronym
HBOTLC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID 328078 0
Condition category
Condition code
Infection 325138 325138 0 0
Other infectious diseases
Respiratory 325208 325208 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 325209 325209 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment is hyperbaric oxygen daily for 10 days (mon to Friday) for 90 mins at 2.4 ATA (atmospheres absolute). This is a commonly used treatment table known as a US Navy Table 14 ( USNTable 14). The period may be over more than two weeks if the participant has any intercurrent illness which prevents ear equalisation and requires deferment.
Oxygen is given in a multiplace chamber by TGA approved hoods or masks depending on participant preference and comfort of fit. They sit in an easy recliner for the duration of treatment.
The treatment is given by certified Hyperbaric physicians in an accredited hyperbaric facility under the oversight of a Senior ANZCA accredited Hyperbaric Physician and Anaesthetist.
Intervention code [1] 324748 0
Treatment: Devices
Comparator / control treatment
Control group id no HBOT
Control group
Active

Outcomes
Primary outcome [1] 332963 0
Neurocognitive assessment measured by Neurotrax software. A computer-based neurocognitive assessment.
Timepoint [1] 332963 0
Baseline and 3 months post-treatment completion
Secondary outcome [1] 415335 0
Lung function testing with bedside vitalograph measuring FEV1 and PEFR.
Timepoint [1] 415335 0
Baseline and 3 months post-treatment
Secondary outcome [2] 415337 0
Chalder fatigue scale
Timepoint [2] 415337 0
Baseline,3 months and 6 months post-treatment completion
Secondary outcome [3] 415339 0
one min sit to stand test to define exercise capacity
Timepoint [3] 415339 0
Baseline and 3 months post-treatment
Secondary outcome [4] 415598 0
adverse side effects such as barotrauma, CNS oxygen toxicity, or myopia (all routinely collected for all patients undergoing HBOT). The participants have daily checks to ensure they have no complications and this is recorded in our medical records and also collated as deidentified data for our national data registry of side effects which all chambers in Australia contribute to for quality assurance.
Timepoint [4] 415598 0
Immediately on Completion of HBOT treatment and again at the three-month post completion visit.

Eligibility
Key inclusion criteria
• 18 to 65-year old
• COVID-19 at least 12 weeks prior, +PCR test/ RAT and/or documented clinical symptoms
• Active lifestyle before contracting COVID-19
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant or lactating women
• Individuals that are unable walk or get in and out of bed by themselves unaided
• Inability to provide written informed consent
• Inability or unwillingness to adhere to 10 HBOT treatment sessions over a 2 to 3 week- time period or to complete questionnaires/testing
• Claustrophobia and inability to enter the hyperbaric chamber for session
• Inability to effectively equalise the middle ear during ambient pressure changes. History of tympanic membrane perforation, head and neck surgery with compromised Eustachian tube function, including tracheostomy, mastoidectomy, middle ear surgical procedures and cochlear implants
• Contraindication to HBOT such as cardiac or respiratory contraindication, bleomycin, spherocytosis or pulmonary fibrosis
• Involved in another clinical trial that does not allow enrolment in other clinical trials

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation by randomised sequence produced off site with sealed opaque envelopes assignment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/12/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 38874 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 304054 0
Self funded/Unfunded
Name [1] 304054 0
Mr Tony Turner
Country [1] 304054 0
Australia
Primary sponsor type
Hospital
Name
Wesley Hyperbaric
Address
Wesley hyperbaric
53 Sandford Jackson Building
30 Chasely St Auchenflower
QLD 4066
Country
Australia
Secondary sponsor category [1] 314142 0
None
Name [1] 314142 0
Address [1] 314142 0
Country [1] 314142 0
Other collaborator category [1] 282469 0
Individual
Name [1] 282469 0
Prof Van Zundert
Address [1] 282469 0
Royal Brisbane and Women's Hospital
Academic Chair of Anaesthesia
Butterfield St
Herston QLD 4209
Country [1] 282469 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304546 0
University of Queensland
Ethics committee address [1] 304546 0
University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 304546 0
Australia
Date submitted for ethics approval [1] 304546 0
14/11/2022
Approval date [1] 304546 0
Ethics approval number [1] 304546 0

Summary
Brief summary
Hyperbaric oxygen is the provision of oxygen in a compression chamber.The aim of this trial is to test the hypothesis that hyperbaric oxygen treatment (HBOT) may improve symptoms in people with Long-COVID . We will compare symptoms of those allocated to the HBOT to participants allocated to no HBOT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97334 0
Dr Susannah Sherlock
Address 97334 0
c/o
Wesley hyperbaric
Ground floor Sandford Jackson Building
30 Chasely st Auchenflower Qld 4066
Country 97334 0
Australia
Phone 97334 0
+61 418510347
Fax 97334 0
Email 97334 0
[email protected]
Contact person for public queries
Name 97335 0
Susannah Sherlock
Address 97335 0
c/o
Wesley hyperbaric
Ground floor Sandford Jackson Building
30 Chasely st Auchenflower Qld 4066
Country 97335 0
Australia
Phone 97335 0
+61 418510347
Fax 97335 0
Email 97335 0
[email protected]
Contact person for scientific queries
Name 97336 0
Susannah Sherlock
Address 97336 0
c/o
Wesley hyperbaric
Ground floor Sandford Jackson Building
30 Chasely st Auchenflower Qld 4066
Country 97336 0
Australia
Phone 97336 0
+61 418510347
Fax 97336 0
Email 97336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17492Study protocol    378569-(Uploaded-08-11-2022-11-34-02)-Study-related document.docx



Results publications and other study-related documents

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