None listed
Conditions
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.
Interventions
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
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Exclusion criteria
Pregnancy <16 weeks’ gestation Not requiring oxygen Contraindications to receiving corticosteroids
Outcome results
None listed