TY - JOUR T1 - Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.03036-2021 VL - 59 IS - 3 SP - 2103036 AU - Alvar Agustí AU - Gaston De Stefano AU - Alberto Levi AU - Xavier Muñoz AU - Christian Romero-Mesones AU - Oriol Sibila AU - Alejandra Lopez-Giraldo AU - Vicente Plaza Moral AU - Elena Curto AU - Andrés L. Echazarreta AU - Silvana E. Márquez AU - Sergi Pascual-Guàrdia AU - Salud Santos AU - Alicia Marin AU - Luis Valdés AU - Fernando Saldarini AU - Clara Salgado AU - Georgina Casanovas AU - Sara Varea AU - José Ríos AU - Rosa Faner Y1 - 2022/03/01 UR - http://erj.ersjournals.com/content/59/3/2103036.abstract N2 - SARS-CoV-2 vaccines have been extremely effective in reducing the incidence of severe coronavirus disease 2019 (COVID-19) [1, 2], but effective and safe treatments for acute infection are still limited [3, 4]. An uncontrolled pulmonary inflammatory response to SARS-CoV-2 is considered a key pathogenic mechanism of COVID-19 progression [5], so systemic dexamethasone is recommended in severe cases [4, 6]. On the other hand, in very mild patients at home, inhaled corticosteroids (ICS) may prevent disease progression [7–10]. Whether ICS can also prevent disease progression in patients hospitalised because of COVID-19 has not been explored previously. Accordingly, we designed an investigator-initiated, open-label, randomised clinical trial (RCT) to explore the efficacy of adding inhaled budesonide to usual care to prevent disease progression in patients hospitalised because of COVID-19 pneumonia. We also carefully monitored the safety of this intervention since there are concerns about the use of systemic corticosteroids in other viral (influenza) lung infections [11].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/3tEQo3pAuthors thank all participants in the study for their willingness to contribute to medical research, and the Barcelona Respiratory Network (www.brn.cat) for facilitating collaborative research. We also acknowledge the support of the Clinical Trial Unit (L. Aparicio, J.A. Arnaiz), the Medical Statistics Core Facility (F. Torres, G. Domenech) of IDIBAPS-Hospital Clinic Barcelona in Spain, the members of the DSMB (B. Cosio, J.M. Miro, F. Barbe, F. Torres) as well as Klixar in Argentina (F. Licastro), for their support during the conduct of the trial and analysis of results. Finally, we acknowledge the economic and logistic support of AstraZeneca (Ana Perez and Gonzalo de Miquel). ER -