TY - JOUR T1 - Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.02808-2020 VL - 56 IS - 6 SP - 2002808 AU - Maryam Edalatifard AU - Maryam Akhtari AU - Mohammadreza Salehi AU - Zohre Naderi AU - Ahmadreza Jamshidi AU - Shayan Mostafaei AU - Seyed Reza Najafizadeh AU - Elham Farhadi AU - Nooshin Jalili AU - Masoud Esfahani AU - Besharat Rahimi AU - Hossein Kazemzadeh AU - Maedeh Mahmoodi Aliabadi AU - Tooba Ghazanfari AU - Mohammadreza Sattarian AU - Hourvash Ebrahimi Louyeh AU - Seyed Reza Raeeskarami AU - Saeidreza Jamalimoghadamsiahkali AU - Nasim Khajavirad AU - Mahdi Mahmoudi AU - Abdolrahman Rostamian Y1 - 2020/12/01 UR - http://erj.ersjournals.com/content/56/6/2002808.abstract N2 - Introduction There are no determined treatment agents for severe COVID-19. It is suggested that methylprednisolone, as an immunosuppressive treatment, can reduce the inflammation of the respiratory system in COVID-19 patients.Methods We conducted a single-blind, randomised controlled clinical trial involving severe hospitalised patients with confirmed COVID-19 at the early pulmonary phase of the illness in Iran. The patients were randomly allocated in a 1:1 ratio by the block randomisation method to receive standard care with methylprednisolone pulse (intravenous injection, 250 mg·day−1 for 3 days) or standard care alone. The study end-point was the time of clinical improvement or death, whichever came first. Primary and safety analysis was done in the intention-to-treat (ITT) population.Results 68 eligible patients underwent randomisation (34 patients in each group) from April 20, 2020 to June 20, 2020. In the standard care group, six patients received corticosteroids by the attending physician before the treatment and were excluded from the overall analysis. The percentage of improved patients was higher in the methylprednisolone group than in the standard care group (94.1% versus 57.1%) and the mortality rate was significantly lower in the methylprednisolone group (5.9% versus 42.9%; p<0.001). We demonstrated that patients in the methylprednisolone group had a significantly increased survival time compared with patients in the standard care group (log-rank test: p<0.001; hazard ratio 0.293, 95% CI 0.154–0.556). Two patients (5.8%) in the methylprednisolone group and two patients (7.1%) in the standard care group showed severe adverse events between initiation of treatment and the end of the study.Conclusions Our results suggest that methylprednisolone pulse could be an efficient therapeutic agent for hospitalised severe COVID-19 patients at the pulmonary phase.This study showed that methylprednisolone pulse administration at the beginning of the early pulmonary phase of illness decreased the mortality rate and improved pulmonary involvement, oxygen saturation and inflammatory markers in COVID-19 patients https://bit.ly/3hik4JB ER -