An interesting paper by Yu and others sought to answer this question.
A previous efficacy trial found benefit from inhaled budesonide for COVID-19 patients not admitted to hospital but effectiveness in high risk individuals is unknown.
This trial aimed to establish whether inhaled budesonide reduced time to recovery and COVID-19 related hospital admissions or deaths amongst patients at high risk of complications in the community.
The principal trial is a multicentre, open label, multi arm, randomised, controlled, adapted platform trial done remotely from a central trial site and at primary care centres in the United Kingdom.
Eligible participants are aged 65-years or older or 50-years-old or older with comorbidities and had been unwell for up to 14 days with suspected COVID-19 but not admitted to hospital.
Participants were randomly assigned to usual care, usual care plus inhaled budesonide or usual care plus other interventions. The budesonide dose was 800 mcg twice daily for 14 days. These patients were all followed up for 28 days.
Participants were aware of the group assignment. The co primary endpoints were time to first self-reported recovery and hospital admission or death related to COVID-19, within 17 days, analysed using Bayesian models.
The primary analysis population included all eligible SARS-CoV-2 positive participants randomly assigned to budesonide, usual care and other interventions. From the start of the platform trial entry to budesonide group was closed.
Findings
The trial began enrolment on April 2nd 2020 with randomisation to budesonide from November 27th 2020 until March 31st 2021 and this was when the pre-specified time to recovery superiority criterion were met.
4700 participants were randomly assigned to the budesonide group, 1073 usual care alone group, 1988 or other treatments 1639.
The primary analysis model included 2530 SARS-CoV-2 positive patients with 787 in the budesonide group, 1069 in the usual care group, and 974 receiving other treatment.
There was a benefit in time to first self-reported recovery of an estimated 2.94 days in the budesonide group versus the usual care group with a probability of superiority greater than 0.999 meeting the pre-specified superiority threshold of 0.99.
For the hospital admission or death outcome, the estimated rate was 6.8% in the budesonide group versus 8.8% in the usual care group with a probability superiority of 0.963, below the pre-specified superiority threshold of 0.975.
Two participants in the budesonide group and four in the usual care group had serious adverse events, which were hospital admissions unrelated to COVID-19.
The trial found that inhaled budesonide improved the time to recovery with the chance of also reducing hospital admissions or deaths in people with COVID-19 in the community who are at higher risk of complications.
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- PCR swabbing
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- COVID support for those patients with COVID and a full multidisciplinary team approach to patients suffering with long COVID or post-acute COVID.
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Dr Paul Ettlinger
BM, DRCOG, FRCGP, FRIPH, DOccMed