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
246 Clayton Road
Clayton
3168
Vic
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
Dexamethasone has been shown to effectively reduce the incidence of death in hospitalised patients with COVID-19 who require oxygen supplementation and invasive ventilation.
Prednisolone is the same class of drug ( steroid) however it does not cross the placenta. therefore we wonder if we can use prednisolone instead of dexamethasone to create women with covid-19 in pregnancy and reduce risks to the baby.

The TGA advise that dexamethasone is a category C drug in pregnancy, prednisolone is category A.

There are no trials (published or in progress) comparing efficacy of dexamethasone versus prednisolone in the treatment of COVID-19 in pregnancy. A non-inferiority study may prove similar maternal mortality reductions with minimal fetal effects.

It is expected that prednisolone will prevent deteriorating illness as well as dexamethasone without exposing the fetus to the effects of the steroids treatment.
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
carole-anne.whigham@monashhealth.org
Contact person for public queries
Name 115483 0
Dr 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
carole-anne.whigham@monashhealth.org
Contact person for scientific queries
Name 115484 0
Dr 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
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
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.