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Review 1: "Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial"

This study suggests that budesonide, a corticosteroid used for COPD and asthma treatment, reduces the likelihood of urgent care, ED visit, or hospitalization in patients with early COVID-19; both reviewers found the study findings to be reasonable and potentially reliable.

Published onApr 26, 2021
Review 1: "Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial"
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key-enterThis Pub is a Review of
Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial

AbstractBackgroundMultiple early hospital cohorts of coronavirus disease 2019 (COVID-19) showed that patients with chronic respiratory disease were significantly under-represented. We hypothesised that the widespread use of inhaled glucocorticoids was responsible for this finding and tested if inhaled glucorticoids would be an effective treatment for early COVID-19 illness.MethodsWe conducted a randomised, open label trial of inhaled budesonide, compared to usual care, in adults within 7 days of the onset of mild Covid-19 symptoms. The primary end point was COVID-19-related urgent care visit, emergency department assessment or hospitalisation. The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment.Results146 patients underwent randomisation. For the per protocol population (n=139), the primary outcome occurred in 10 participants and 1 participant in the usual care and budesonide arms respectively (difference in proportion 0.131, p=0.004). The number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was 8. Clinical recovery was 1 day shorter in the budesonide arm compared to the usual care arm (median of 7 days versus 8 days respectively, logrank test p=0.007). Proportion of days with a fever and proportion of participants with at least 1 day of fever was lower in the budesonide arm. Fewer participants randomised to budesonide had persistent symptoms at day 14 and day 28 compared to participants receiving usual care.ConclusionEarly administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery following early COVID-19 infection.(Funded by Oxford NIHR Biomedical Research Centre and AstraZeneca; number, NCT04416399)Research in contextEvidence before this studyThe majority of interventions studied for the COVID-19 pandemic are focused on hospitalised patients. Widely available and broadly relevant interventions for mild COVID-19 are urgently needed.Added value of this studyIn this open label randomised controlled trial, inhaled budesonide, when given to adults with early COVID-19 illness, reduces the likelihood of requiring urgent care, emergency department consultation or hospitalisation. There was also a quicker resolution of fever, a known poor prognostic marker in COVID-19 and a faster self-reported and questionnaire reported symptom resolution. There were fewer participants with persistent COVID-19 symptoms at 14 and 28 days after budesonide therapy compared to usual care.Implications of all the available evidenceThe STOIC trial potentially provides the first easily accessible effective intervention in early COVID-19. By assessing health care resource utilisation, the study provides an exciting option to help with the worldwide pressure on health care systems due to the COVID-19 pandemic. Data from this study also suggests a potentially effective treatment to prevent the long term morbidity from persistent COVID-19 symptoms.

RR:C19 Evidence Scale rating by reviewer:

  • Reliable. The main study claims are generally justified by its methods and data. The results and conclusions are likely to be similar to the hypothetical ideal study. There are some minor caveats or limitations, but they would/do not change the major claims of the study. The study provides sufficient strength of evidence on its own that its main claims should be considered actionable, with some room for future revision.



Budesonide was commonly used with chronic respiratory disease, as a representative of glucocorticoids. It is currently clear that budesonide not only suppresses the immune response that occurs when asthma occurs but also has anti-inflammatory effects. Some research found that the high fatality and morbidity rates associated with COVID-19 can be partly attributed to dysregulated immune response and cytokine storm. So, inferring theoretically, the methods and conclusions of this study are reasonable.

Everyone hopes that the pandemic will be effectively controlled, whether through the use of vaccines or pharmaceuticals. Therefore, our research results should be more objective and reasonable than ever. So, I present my opinion on this research. In this study, the primary end point was COVID-19-related urgent care visit, emergency department assessment, or hospitalization. The rationality of the primary study endpoint needs to be further considered. COVID-19 brings a heavy burden to the medical system and, in many cases, the rate of hospitalization is not solely due to illness but may depend on the capacity of the medical system.

In regards to the secondary outcomes (Self-reported clinical recovery), my personal understanding is that self-reported results would be the conclusion drawn by the patients outlining their own feelings, which are subjective, and such an outcome would be difficult to quality control. There are many factors that affect the outcome, such as knowledge of the disease, social status. and medical support, etc. If there is more objective data to supplement the conclusions, the results would be more convincing.

During a pandemic, any work that contributes to disease control and prevention is worth encouraging, so I personally think that the results of this study are gratifying. Of course, I hope that this research will be further improved and made more scientific, which would help in controlling the pandemic.

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