Inhaled budesonide for early treatment of COVID-19

We have thoroughly read the results of the phase 2 randomised clinical trial reported by Sanjay Ramakrishnan and colleagues¹ in The Lancet Respiratory Medicine investigating the role of inhaled budesonide compared with usual care in adults within the first 7 days from the onset of mild COVID-19 symptoms.

The aim of the study is quite appealing and timely. A safe and simple therapy administered early in the course of COVID-19 in an outpatient regimen could be extremely useful for preventing progression and clinical deterioration—with the associated requirement of hospital care—in a large proportion of symptomatic individuals. We acknowledge the effort in designing and successfully conducting an intervention study with such aims, particularly taking into account the logistic difficulties posed by the current pandemic.

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In view of the results of the trial, some benefits of this novel approach could be concluded from the analysis of secondary outcomes, which showed a faster self-reported clinical recovery in patients allocated to inhaled budesonide than among those allocated to usual care. Nevertheless, we believe that the major finding of the study is the effect of budesonide in the prevention of the primary event, defined as COVID-19-related urgent care visits (including emergency department assessment or hospitalisation). In our opinion, the description of the clinical conditions leading to urgent management of the 11 patients (ten in the usual care group and one in the budesonide group) who met the primary outcome in the per-protocol analysis is incomplete and somewhat confusing. The information is briefly presented in the text body of the Results section, with no additional table, which would have helped with clear presentation. On the sole basis of the provided data, we would conclude that only five patients seemed to require urgent medical care due to worsening of COVID-19 (four patients with respiratory deterioration and one with suspected pulmonary embolism). No additional information regarding COVID-19 clinical scenario at that moment was offered. For another three participants, the authors report three outcome events (diabetic ketoacidosis, acute kidney injury, and suspected rib fractures) that could hardly be attributable to COVID-19. Notably, no further information on the nature of the type of event is provided for the three remaining participants.

We believe that a more thorough analysis of these 11 events is necessary to determine the potential benefit of budesonide to decrease the risk of progression of mild COVID-19.

We declare no competing interests.