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The effect of Budesonide on the occurrence of deteriorating Illness from Covid-19 in Pregnant patients ( BUDI trial)

The effect of Budesonide on the occurrence of deteriorating Illness from Covid-19 in Pregnant patients ( BUDI trial): an open label randomised controlled trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001585819
Acronym
BUDI trial
Enrollment
116
Registered
2021-11-19
Start date
2021-11-22
Completion date
2022-08-29
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Sponsors

Monash Health
Lead SponsorHospital

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

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

Exclusion criteria

O2 requiring on dexamethasone, remdesivir or tocilizumab Contraindication to budesonide or taking budesonide outside of trial

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026