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

By Yash S. Huilgol

[1] UC Berkeley-UCSF Joint Medical Program, Berkeley, CA, USA

[2] Editorial Office, Rapid Reviews: COVID-19

Main Claim & Relevance:

In this preprint by Ramakrishnan et al [1], inhaled budesonide, a corticosteroid used for long-term COPD and asthma treatment, reducing the likelihood of urgent care, ED visit, or hospitalization among patients with early COVID-19 illness. This amounted to a relative risk reduction of 90%, or a difference in proportions of 13.1% between the budesonide and standard of care arms.

Are the findings strong, reliable, potentially informative, not informative, or misleading? Why?

The findings are reliable, though the findings need to be confirmed through further studies and assessment. The use of the randomized, open-label phase 2 trial among 149 adults in a per-protocol analysis is well powered, adding to the strength of these claims. The two randomized groups were well-matched, but O2 saturation in the treatment group appeared to have a larger confidence interval than that for the usual care group. However, the study could be improved by the recruitment of a more diverse patient population, of which 93% of participants were white in both arms, and of unknown sociodemographic characteristics.

How might these ideas presented by the main claims further knowledge of the COVID-19 pandemic?

Much of the literature has focused on later stages of COVID-19 disease progression, but there are limited studies of therapeutics for treating mild COVID-19 [2,3].

However, this study claimed that there is a reduction in urgent care, ED, or hospital visits and a reduction in recovery time from COVID-19. Budesonide is also a well-tolerated, ubiquitous, and cheap therapeutic that could alleviate symptoms and reduce escalation of care among COVID-19 patients if taken over a median of 7 days. There remains a concern clinically that administering steroids early in treatment may prevent the immune system from adequately reacting in the early stages of the COVID-19 disease course. Additional studies are needed to verify these findings.

References

[1] Ramakrishnan S, Nicolau DV, Langford B, et al. Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial. medRxiv. Published online January 1, 2021:2021.02.04.21251134. doi:10.1101/2021.02.04.21251134

[2] The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group. Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis. JAMA. 2020;324(13):1330–1341. doi:10.1001/jama.2020.17023

[3] The RECOVERY Collaborative Group. Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report. N Engl J Med. Published online July 17, 2020. doi:10.1056/NEJMoa2021436

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