Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospec
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LETTER
Open Access
Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospective meta-analysis of randomized trials Jonathan A. C. Sterne1,2* , Janet Diaz3, Jesús Villar4,5, Srinivas Murthy6, Arthur S. Slutsky7, Anders Perner8, Peter Jüni7, Derek C. Angus9, Djillali Annane10, Luciano Cesar Pontes Azevedo11, Bin Du12, Pierre-Francois Dequin13,14, Anthony C. Gordon15, Cameron Green16, Julian P. T. Higgins1,2,17, Peter Horby18, Martin J. Landray19,20,21, Giuseppe Lapadula22, Amelie Le Gouge23, Marie Leclerc24, Jelena Savović1,17, Bruno Tomazini11, Balasubramanian Venkatesh25, Steve Webb16, and John C. Marshall26 for the WHO COVID-19 Clinical Management and Characterization Working Group
Abstract Objectives: Primary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events. Study design: Prospective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible. Participants: Hospitalised, critically ill patients with suspected or confirmed COVID-19. Intervention and comparator: Intervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo. Main outcome: All-cause mortality up to 28 days after randomization. (Continued on next page)
* Correspondence: [email protected] 1 Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK 2 NIHR Bristol Biomedical Research Centre, Bristol, UK Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.or
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