Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial

Alvar Agustí, Gaston De Stefano, Alberto Levi, Xavier Muñoz, Christian Romero-Mesones, Oriol Sibila, Alejandra Lopez-Giraldo, Vicente Plaza Moral, Elena Curto, Andrés L Echazarreta, Silvana E Márquez, Sergi Pascual-Guàrdia, Salud Santos, Alicia Marin, Luis Valdés, Fernando Saldarini, Clara Salgado, Georgina Casanovas, Sara Varea, José Ríos, Rosa Faner, Alvar Agustí, Gaston De Stefano, Alberto Levi, Xavier Muñoz, Christian Romero-Mesones, Oriol Sibila, Alejandra Lopez-Giraldo, Vicente Plaza Moral, Elena Curto, Andrés L Echazarreta, Silvana E Márquez, Sergi Pascual-Guàrdia, Salud Santos, Alicia Marin, Luis Valdés, Fernando Saldarini, Clara Salgado, Georgina Casanovas, Sara Varea, José Ríos, Rosa Faner

Abstract

The addition of inhaled budesonide to usual care is safe and may reduce the risk of disease progression in patients hospitalised because of COVID-19 pneumonia https://bit.ly/3tEQo3p

Trial registration: ClinicalTrials.gov NCT04355637.

Conflict of interest statement

Conflict of interest: All authors declare support from AstraZeneca (provision of study drugs for the present manuscript). A. Agustí declares grant support from AstraZeneca, GlaxoSmithKline and Menarini; consulting fees and payment or honoraria from AstraZeneca, Chiesi and GlaxoSmithKline; and payment or honoraria from Menarini, all in the 36 months prior to manuscript submission. X. Muñoz declares grant support from AstraZeneca, GlaxoSmithKline and Sanofi; consulting fees and support for attending meetings and/or travel from AstraZeneca, GlaxoSmithKline and Novartis; payment or honoraria from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim and Sanofi; and participation on a data safety monitoring board or advisory board for GlaxoSmithKline and Chiesi, all in the 36 months prior to manuscript submission. V. Plaza Moral declares grant support from AstraZeneca, GlaxoSmithKline and Sanofi; consulting fees from AstraZeneca, GlaxoSmithKline and Novartis; payment or honoraria from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim and Chiesi; payment for expert testimony from AstraZeneca and Chiesi; support for attending meetings and/or travel from AstraZeneca and Chiesi; and participation on a data safety monitoring board or advisory board for GlaxoSmithKline, Chiesi and AstraZeneca, all in the 36 months prior to manuscript submission. R. Faner declares grant support from AstraZeneca, GlaxoSmithKline and Menarini, in the 36 months prior to manuscript submission. G. De Stefano, A. Levi, C. Romero-Mesones, O. Sibila, A. Lopez-Giraldo, E. Curto, A.L. Echazarreta, S.E. Márquez, S. Pascual-Guàrdia, S. Santos, A. Marin, L. Valdés, F. Saldarini, C. Salgado, G. Casanovas, S. Varea and J. Ríos declare no additional competing interests.

References

    1. Thompson MG, Stenehjem E, Grannis S, et al. . Effectiveness of Covid-19 vaccines in ambulatory and inpatient care settings. N Engl J Med 2021; 385: 1355–1371. doi:10.1056/NEJMoa2110362
    1. Polack FP, Thomas SJ, Kitchin N, et al. . Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 2020; 383: 2603–2615.
    1. Beigel JH, Tomashek KM, Dodd LE, et al. . Remdesivir for the treatment of Covid-19 — final report. N Engl J Med 2020; 383: 1813–1826. doi:10.1056/NEJMoa2007764
    1. The Recovery Collaborative Group . Dexamethasone in hospitalized patients with Covid-19. N Engl J Med 2020; 384: 693–704.
    1. Siddiqi HK, Mehra MR. COVID-19 illness in native and immunosuppressed states: a clinical-therapeutic staging proposal. J Heart Lung Transplant 2020; 39: 405–407. doi:10.1016/j.healun.2020.03.012
    1. WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group , Sterne JAC, Murthy S, et al. . Association between administration of systemic corticosteroids and mortality among critically ill patients with COVID-19: a meta-analysis. JAMA 2020; 324: 1330–1341.
    1. Ramakrishnan S, Nicolau DV, Langford B, et al. . Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial. Lancet Respir Med 2021; 9: 763–772.
    1. Yu L-M, Bafadhel M, Dorward J, et al. . Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial. Lancet 2021; 398: 843–855. doi:10.1016/S0140-6736(21)01744-X
    1. Agusti A, Torres F, Faner R. Early treatment with inhaled budesonide to prevent clinical deterioration in patients with COVID-19. Lancet Respir Med 2021; 9: 682–683. doi:10.1016/S2213-2600(21)00171-5
    1. Clemency BM, Varughese R, Gonzalez-Rojas Y, et al. . Efficacy of inhaled ciclesonide for outpatient treatment of adolescents and adults with symptomatic COVID-19: a randomized clinical trial. JAMA Intern Med 2021; 182: 42–49.
    1. Zhou Y, Fu X, Liu X, et al. . Use of corticosteroids in influenza-associated acute respiratory distress syndrome and severe pneumonia: a systemic review and meta-analysis. Sci Rep 2020; 10: 3044. doi:10.1038/s41598-020-59732-7
    1. Cao B, Wang Y, Wen D, et al. . A trial of lopinavir–ritonavir in adults hospitalized with severe Covid-19. N Engl J Med 2020; 382: 1787–1799. doi:10.1056/NEJMoa2001282
    1. Wacholder S. Binomial regression in GLIM: estimating risk ratios and risk differences. Am J Epidemiol 1986; 123: 174–184. doi:10.1093/oxfordjournals.aje.a114212
    1. Greenland S. Model-based estimation of relative risks and other epidemiologic measures in studies of common outcomes and in case-control studies. Am J Epidemiol 2004; 160: 301–305. doi:10.1093/aje/kwh221

Source: PubMed

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