Methylprednisolone for hospitalised severe Covid-19 patients: randomised controlled clinical trial

Maryam Edalatifard, Maryam Akhtari, Mohammadreza Salehi, Zohre Naderi, Ahmadreza Jamshidi, Shayan Mostafaei, Seyed Reza Najafizadeh, Elham Farhadi, Nooshin Jalili, Masoud Esfahani, Besharat Rahimi, Hossein Kazemzadeh, Maedeh Mahmoodi Aliabadi, Tooba Ghazanfari, Mohammad Reza Satarian, Hourvash Ebrahimi Louyeh, Seyed Reza Raeeskarami, Saeidreza Jamali Moghadam Siahkali, Nasim Khajavirad, Mahdi Mahmoudi, Abdorahman Rostamian

European Respiratory Journal 2020;

DOI: 10.1183/13993003.02808-2020

PDF: https://erj.ersjournals.com/content/erj/early/2020/09/09/13993003.02808-2020.full.pdf

Abstract

Background There are no determined treatment agents for the severe coronavirus disease 2019 (COVID-19); therefore, it is suggested that methylprednisolone, as an immunosuppressive treatment, can reduce the inflammation of the respiratory system.

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 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 endpoint 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 Sixty-eight eligible patients underwent randomisation (34 patients in each group) from April 20, till Jun 20, 2020. In the standard care group, six patients received corticosteroids by the attending physician during treatment and excluded from the ITT population. Patients with clinical improvement were higher in the methylprednisolone group than in the standard care group (94·1% versus 57·1%), and the mortality rate was numerically lower in the methylprednisolone group (5·9% versus 42.9%; p <0·001). We demonstrated that patients in the methylprednisolone intervention group had a significantly increased survival time compared with the patients in the standard care group [Log rank test: p<0.001; Hazard ratio: 0.293; 95% C‎‎I: 0.‎154–0.556]. A total of two patients in each group (5·8% and 7·1% respectively) showed severe adverse events between initiation of treatment and the end of the study.

Conclusions Our results suggested that methylprednisolone pulse could be an efficient therapeutic agent for hospitalised severe COVID-19 patients at the pulmonary phase.

https://erj.ersjournals.com/content/early/2020/09/09/13993003.02808-2020