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 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 - 2022/01/01 UR - http://erj.ersjournals.com/content/early/2022/01/13/13993003.03036-2021.abstract N2 - SARS-CoV-2 vaccines have been extremely effective to reduce the incidence of severe COVID19 [1–3], but effective and safe treatments of the acute infection are still limited [4, 5]. An uncontrolled pulmonary inflammatory response to SARS-CoV-2 is considered a key pathogenic mechanism of COVID19 progression [6], so systemic dexamethasone is recommended in severe cases [5, 7]. On the other hand, in very mild patients at home inhaled corticosteroids (ICS) may prevent disease progression [8–11]. Whether ICS prevent disease progression too in patients hospitalised because of COVID19 has not been explored before. 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 COVID19 pneumonia. We also monitored carefully the safety of this intervention since there are concerns about the use of systemic corticosteroids in other viral (influenza) lung infections [12].Acknowledgments: Authors thank all participants in the study for their willingness to contribute to medical research, and the Barcelona Respiratory Network (www.brn.cat) to facilitate collaborative research. We also acknowledge the support of the Clinical Trial Unit (L. Aparicio, JA Arnaiz), the Medical Statistics Core Facility (F. Torres, G. Domenech) of IDIBAPS-Hospital Clinic Barcelona in Spain, the members of the DSMB (Drs. B. Cosio, JM. 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 (Dra. Ana Perez and Dr. Gonzalo de Miquel). ER -