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

Phase 3

• Conditions: Covid-19; Reproductive Health and Childbirth - Normal pregnancy; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621001585819
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-19
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 116

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>This will be collected from information on the electronic medical records[during hospital admission]

Secondary Outcome Measures

Name	Time	Method
duration of symptoms ( assessed by flupro questionnaire or common cold questionnaire) <br>[during hospital admission];gestation at delivery. This will be assessed from medical records[end of pregnancy];oxygen saturations below 94% while in hospital. This will be assessed using electronic medical records[during hospital stay]; duration of hospital admission. This will be assessed from electronic medical records[ duration of hospital admission, ];neonatal complications including admission to NICU.This will be assessed from electronic medical records[first 5 days after birth]