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Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial.
Edalatifard, Maryam; Akhtari, Maryam; Salehi, Mohammadreza; Naderi, Zohre; Jamshidi, Ahmadreza; Mostafaei, Shayan; Najafizadeh, Seyed Reza; Farhadi, Elham; Jalili, Nooshin; Esfahani, Masoud; Rahimi, Besharat; Kazemzadeh, Hossein; Mahmoodi Aliabadi, Maedeh; Ghazanfari, Tooba; Sattarian, Mohammadreza; Ebrahimi Louyeh, Hourvash; Raeeskarami, Seyed Reza; Jamalimoghadamsiahkali, Saeidreza; Khajavirad, Nasim; Mahmoudi, Mahdi; Rostamian, Abdolrahman.
  • Edalatifard M; Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Akhtari M; These two authors contributed equally as first authors.
  • Salehi M; Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Naderi Z; Inflammation Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Jamshidi A; These two authors contributed equally as first authors.
  • Mostafaei S; Dept of Infectious and Tropical Medicines, Tehran University of Medical Sciences, Tehran, Iran.
  • Najafizadeh SR; Dept of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
  • Farhadi E; Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Jalili N; These three authors contributed equally as lead authors and supervised the work.
  • Esfahani M; Dept of Biostatistics, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.
  • Rahimi B; Rheumatology Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.
  • Kazemzadeh H; Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Mahmoodi Aliabadi M; Inflammation Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Ghazanfari T; Dept of Internal Medicine, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.
  • Sattarian M; Dept of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Ebrahimi Louyeh H; Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Raeeskarami SR; Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Jamalimoghadamsiahkali S; Dept of Laboratory, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
  • Khajavirad N; Immunoregulation Research Center, Shahed University, Tehran, Iran.
  • Mahmoudi M; Simorgh Clinical Laboratory, Tehran, Iran.
  • Rostamian A; Dept of Rheumatology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Eur Respir J ; 56(6)2020 12.
Article in English | MEDLINE | ID: covidwho-781426
ABSTRACT

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 11 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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Methylprednisolone / COVID-19 Drug Treatment / Anti-Inflammatory Agents Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Year: 2020 Document Type: Article Affiliation country: 13993003.02808-2020

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Methylprednisolone / COVID-19 Drug Treatment / Anti-Inflammatory Agents Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Year: 2020 Document Type: Article Affiliation country: 13993003.02808-2020