TY - JOUR T1 - Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.00025-2022 SP - 2200025 AU - Carlo Salvarani AU - Marco Massari AU - Massimo Costantini AU - Domenico Franco Merlo AU - Gabriella Lucia Mariani AU - Pierluigi Viale AU - Stefano Nava AU - Giovanni Guaraldi AU - Giovanni Dolci AU - Luca Boni AU - Luisa Savoldi AU - Paolo Bruzzi AU - Caterina Turrà AU - Mariagrazia Catanoso AU - Anna Maria Marata AU - Chiara Barbieri AU - Annamaria Valcavi AU - Francesca Franzoni AU - Silvio Cavuto AU - Giorgio Mazzi AU - Romina Corsini AU - Fabio Trapani AU - Alessandro Bartoloni AU - Emanuela Barisione AU - Chiara Barbieri AU - Giulia Jole Burastero AU - Angelo Pan AU - Walter Inojosa AU - Raffaele Scala AU - Cecilia Burattini AU - Fabrizio Luppi AU - Mauro Codeluppi AU - Kamal Eldin Tarek AU - Giovanni Cenderello AU - Mario Salio AU - Giuseppe Foti AU - Roberto Dongilli AU - Gianluigi Bajocchi AU - Emanuele Alberto Negri AU - Giacomo Ciusa AU - Giacomo Fornaro AU - Ilaria Bassi AU - Lorenzo Zammarchi AU - Teresita Aloè AU - Nicola Facciolongo Y1 - 2022/01/01 UR - http://erj.ersjournals.com/content/early/2022/03/17/13993003.00025-2022.abstract N2 - Rationale Pulse glucocorticoid therapy is used in hyperinflammation related to coronavirus 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia.Methods In this multicenter, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with Covid-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for 3 consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of the patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need of supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival.Results Overall, 112 of 151 (75.4%) patients in the pulse methylprednisolone arm and 111 of 150 (75.2%) in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups [15 days (95% confidence interval (CI), 13.0 to 17.0) and 16 days (95%CI, 13.8 to 18.2); hazard ratio (HR), 0.92; 95% CI 0.71–1.20; p=0.528]. No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to Intensive Care Unit with orotracheal intubation or death (20.0% versus 16.1%; HR, 1.26; 95%CI, 0.74–2.16; p=0.176), or overall mortality (10.0% versus 12.2%; HR, 0.83; 95%CI, 0.42–1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups.Conclusions Methylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia.Message of the study Pulse glucocorticoid therapy is used for severe and/or life threatening immuno-inflammatory diseases. The addition of pulse glucocorticoid therapy to the standard low dose of dexamethasone scheme was not of benefit in patients with COVID-19 pneumonia. ER -