Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001603808
Ethics application status
Approved
Date submitted
10/11/2021
Date registered
24/11/2021
Date last updated
24/11/2021
Date data sharing statement initially provided
24/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Prednisolone vs Dexamethasone on Covid-19 in Pregnancy: an open labelled randomised control trial
Scientific title
The effect of Prednisolone vs Dexamethasone on Covid-19 in Pregnancy: an open labelled randomised control trial
Secondary ID [1] 305769 0
nil known
Universal Trial Number (UTN)
U1111-1271-4666
Trial acronym
PROVED-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
covid-19 324273 0
pregnancy 324274 0
Condition category
Condition code
Reproductive Health and Childbirth 321767 321767 0 0
Fetal medicine and complications of pregnancy
Infection 321806 321806 0 0
Other infectious diseases
Respiratory 321807 321807 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prednisolone 50mg in tablet form once per day for up to 10 days.
Prednisolone will be administered while in hospital for a maximum of 10 days but if the patient is discharged before then it will be ceased.
This will be administered by a nurse to ensure compliance
Intervention code [1] 322167 0
Treatment: Drugs
Comparator / control treatment
Dexamethasone 6mg in tablet form for up to 10 days.
Dexamethasone will be administered while in hospital for a maximum of 10 days but if the patient is discharged before then it will be ceased.
this will be administered by a nurse to ensure compliance
Control group
Active

Outcomes
Primary outcome [1] 329515 0
WHO ordinal scale of clinical improvement compared at day 5 and at day 10.
Timepoint [1] 329515 0
day 5 and 10 of admission to hospital.
This is a comparative study.
Both of these are the primary timepoints
Secondary outcome [1] 402834 0
duration of admission to hospital,




Timepoint [1] 402834 0
at discharge from hospital. This information will be obtained via medical records
Secondary outcome [2] 403014 0
gestation at delivery
Timepoint [2] 403014 0
end of pregnancy from medical records
Secondary outcome [3] 403015 0
Deteriorating to ICU admission ( if not already in ICU),
Timepoint [3] 403015 0
during hospital admission. this will be obtained from medical records
Secondary outcome [4] 403016 0
length of stay in ICU
Timepoint [4] 403016 0
during hospital admission. This will be obtained from medical records
Secondary outcome [5] 403017 0
need for intubation/NIV, death. This is a composite outcome
Timepoint [5] 403017 0
during hospital admission. This will be obtained from hospital records
Secondary outcome [6] 403018 0
Blood sugar management including insulin regimen.
Timepoint [6] 403018 0
during hospital admission. This will be obtained from medical records
Secondary outcome [7] 403019 0
Fetal USS parameters of well-being, including fetal dopplers, AFI and growth measurements (from routinely ordered USS two weeks post covid illness)
Timepoint [7] 403019 0
This will be obtained from medical records
Secondary outcome [8] 403020 0
Neonatal complications including admission to NICU, apgar scores, if respiratory support is needed for the baby, death, blood sugar control.
Timepoint [8] 403020 0
during hospital admission, This information will be obtained from medical records
Secondary outcome [9] 403021 0
Fetal cord and early newborn lactates. This will be assessed as a composite
Timepoint [9] 403021 0
during hospital admission. This information will be obtained from medical records
Secondary outcome [10] 403023 0
Requirement for delivery of fetus for maternal respiratory compromise.
Timepoint [10] 403023 0
During hospital admission. This information will be obtained from medical records

Eligibility
Key inclusion criteria
Pregnant women >16 weeks with COVID-19, hospitalised with an oxygen requirement.
Comorbidities are included, not limited to obesity, hypertension, diabetes, pre-existing illnesses are included.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy <16 weeks’ gestation
Not requiring oxygen
Contraindications to receiving corticosteroids

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 programme
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
Based on the paper by Ranjbar et al, using a non-inferiority design, we have calculated the sample size.
We have defined a non-inferiority margin for the rate of the primary outcome as 1 point on the OSCI scale, using standard deviations from the above trial. For a one-sided alpha of 0.025 and power of 80%, we will need 91 patients in each group. We expect 5% may be lost to follow up, therefore have adjusted the sample size to 192.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
9/11/2022
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21071 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 35924 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 310126 0
Hospital
Name [1] 310126 0
Monash Health
Country [1] 310126 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton
3168
Victoria
Country
Australia
Secondary sponsor category [1] 311194 0
None
Name [1] 311194 0
na
Address [1] 311194 0
na
Country [1] 311194 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309814 0
monash health research ethics committee
Ethics committee address [1] 309814 0
Ethics committee country [1] 309814 0
Australia
Date submitted for ethics approval [1] 309814 0
29/10/2021
Approval date [1] 309814 0
09/11/2021
Ethics approval number [1] 309814 0
RES-21-0000-704A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115482 0
Dr Carole-Anne Whigham
Address 115482 0
Monash health
246 Clayton Road
Clayton
3168
Vic
Country 115482 0
Australia
Phone 115482 0
+61 404644029
Fax 115482 0
Email 115482 0
[email protected]
Contact person for public queries
Name 115483 0
Carole-Anne Whigham
Address 115483 0
Monash Health
246 Clayton Road
Clayton
3168
Vic
Country 115483 0
Australia
Phone 115483 0
+61 404644029
Fax 115483 0
Email 115483 0
[email protected]
Contact person for scientific queries
Name 115484 0
Carole-Anne Whigham
Address 115484 0
Monash Health
246 Clayton Road
Clayton
3168
Vic
Country 115484 0
Australia
Phone 115484 0
+61 404644029
Fax 115484 0
Email 115484 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
I have no intention to share this data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14039Study protocol    383106-(Uploaded-15-11-2021-15-51-34)-Study-related document.docx
14095Informed consent form    383106-(Uploaded-15-11-2021-15-52-06)-Study-related document.docx



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.