Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001585819
Ethics application status
Approved
Date submitted
9/11/2021
Date registered
19/11/2021
Date last updated
19/11/2021
Date data sharing statement initially provided
19/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Budesonide on the occurrence of deteriorating Illness from Covid-19 in Pregnant patients ( BUDI trial)
Scientific title
The effect of Budesonide on the occurrence of deteriorating Illness from Covid-19 in Pregnant patients ( BUDI trial): an open label randomised controlled trial
Secondary ID [1] 305756 0
nil known
Universal Trial Number (UTN)
U1111-1271-3550
Trial acronym
BUDI trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid-19 324257 0
Condition category
Condition code
Reproductive Health and Childbirth 321753 321753 0 0
Normal pregnancy
Infection 321804 321804 0 0
Other infectious diseases
Respiratory 321805 321805 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Budesonide inhaled 400micrograms 2 puffs twice per day while in hospital for up to 2 weeks.
This will be supervised by a nurse who will give the inhaler
Intervention code [1] 322161 0
Treatment: Drugs
Comparator / control treatment
Standard care does not involve any inhalers. Standard care is supportive with high flow air and medication to reduce fever and pain
Control group
Active

Outcomes
Primary outcome [1] 329504 0
composite of deteriorating to require oxygen therapy to maintain oxygen saturations above 94% , admission to ICU, death, requirement for delivery of fetus for maternal respiratory compromise.
This will be collected from information on the electronic medical records
Timepoint [1] 329504 0
during hospital admission
Secondary outcome [1] 402797 0
duration of symptoms ( assessed by flupro questionnaire or common cold questionnaire)
Timepoint [1] 402797 0
during hospital admission
Secondary outcome [2] 403010 0
gestation at delivery. This will be assessed from medical records
Timepoint [2] 403010 0
end of pregnancy
Secondary outcome [3] 403011 0
oxygen saturations below 94% while in hospital. This will be assessed using electronic medical records
Timepoint [3] 403011 0
during hospital stay
Secondary outcome [4] 403012 0
duration of hospital admission. This will be assessed from electronic medical records
Timepoint [4] 403012 0
duration of hospital admission,
Secondary outcome [5] 403013 0
neonatal complications including admission to NICU.This will be assessed from electronic medical records
Timepoint [5] 403013 0
first 5 days after birth

Eligibility
Key inclusion criteria
covid symptoms requiring admission to hospital >==16 weeks gestation up to 6 weeks post partum ( including breastfeeding).
Age >18 years
Not requiring O2
Patients with comorbidities including but not limited to asthma ( not on budesonide), diabetes mellitis, hypertension and all others in which budesonide is not contraindicated
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
O2 requiring
on dexamethasone, remdesivir or tocilizumab
Contraindication to budesonide or taking budesonide outside of trial

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
We have carried out a statistical power calculation to calculate sample size. We are aiming for a 50% reduction in primary outcome with the use of budesonide. Using a twi sided alpha value of 0.05 at a power of 80% we will require 55 participants in each arm. Adjusting for a 5% loss to follow up, we aim to recruit 58 participants in each arm.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/11/2021
Actual
Date of last participant enrolment
Anticipated
29/08/2022
Actual
Date of last data collection
Anticipated
21/11/2022
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 35915 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 310116 0
Self funded/Unfunded
Name [1] 310116 0
nil
Country [1] 310116 0
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton
3168
Vic
Country
Australia
Secondary sponsor category [1] 311183 0
None
Name [1] 311183 0
nil
Address [1] 311183 0
nil
Country [1] 311183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309805 0
Monash health Human Research Ethics Committee
Ethics committee address [1] 309805 0
Level 2, I Block, Monash Medical Centre, 246 Clayton Road, Clayton, 3168 VIC
Ethics committee country [1] 309805 0
Australia
Date submitted for ethics approval [1] 309805 0
29/10/2021
Approval date [1] 309805 0
09/11/2021
Ethics approval number [1] 309805 0
RES-21-0000-707A

Summary
Brief summary
Budesonide is an inhaled corticosteroid which is commonly used to treat asthma. It is inexpensive and widely available. Budesonide is a category A drug in pregnancy.
There is evidence that budesonide reduces hospital admission in patients with covid-19 who are not pregnant.
The physiological changes that take place in pregnancy include increased minute ventilation and upwards displacement of the diaphragm which results in a high-risk state for any kind of respiratory compromise. As such, treatments that reduce the risk of these fit young mothers suffering respiratory decompensation are pertinent to the well-being of both the baby and the mother.

This study seeks to determine if budesonide improves outcomes in those hospitalised with covid-19.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 115446 0
Dr carole-anne whigham
Address 115446 0
Monash Health
246 clayton road
Clayton
3168
VIC
Country 115446 0
Australia
Phone 115446 0
+61 404644029
Fax 115446 0
Email 115446 0
carole-anne.whigham@monashhealth.org
Contact person for public queries
Name 115447 0
Dr carole-anne whigham
Address 115447 0
Monash Health
246 clayton road
Clayton
3168
Vic
Country 115447 0
Australia
Phone 115447 0
+61 404644029
Fax 115447 0
Email 115447 0
carole-anne.whigham@monashhealth.org
Contact person for scientific queries
Name 115448 0
Dr carole-anne whigham
Address 115448 0
Monash Health
246 clayton road
Clayton
3168
Vic
Country 115448 0
Australia
Phone 115448 0
+61 404644029
Fax 115448 0
Email 115448 0
carole-anne.whigham@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
we will not be doing this


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.