Effectiveness of glucocorticoid therapy in patients with severe coronavirus disease 2019:protocol of a randomized controlled trial  

作　　者：Yuan-Yuan Qin Yi-Hong Zhou Yan-Qiu Lu Feng Sun Sen Yang Vijay Harypursat Yao-Kai Chen 

机构地区：[1]Division of Infectious Diseases,Chongqing Public Health Medical Center,Chongqing 400036,China

出　　处：《Chinese Medical Journal》2020年第9期1080-1086,共7页中华医学杂志（英文版）

基　　金：This work was supported by the Chongqing Special Research Project for Prevention and Control of Novel Coronavirus Pneumonia(No.cstc2020jscx-fyzx0074)。

摘　　要：Background:At the end of 2019,a novel coronavirus outbreak causative organism has been subsequently designated the 2019 novel coronavirus(2019-nCoV).The effectiveness of adjunctive glucocorticoid therapy in the management of 2019-nCoV-infected patients with severe lower respiratory tract infections is not clear,and warrants further investigation.Methods:The present study will be conducted as an open-labeled,randomized,controlled trial.We will enrol 48 subjects from Chongqing Public Health Medical Center.Each eligible subject will be assigned to an intervention group(methylprednisolone via intravenous injection at a dose of 1-2 mg/kg/day for 3 days)or a control group(no glucocorticoid use)randomly,at a 1:1 ratio.Subjects in both groups will be invited for 28 days of follow-up which will be scheduled at four consecutive visit points.We will use the clinical improvement rate as our primary endpoint.Secondary endpoints include the timing of clinical improvement after intervention,duration of mechanical ventilation,duration of hospitalization,overall incidence of adverse events,as well as rate of adverse events at each visit,and mortality at 2 and 4 weeks.Discussion:The present coronavirus outbreak is the third serious global coronavirus outbreak in the past two decades.Oral and parenteral glucocorticoids have been used in the management of severe respiratory symptoms in coronavirus-infected patients in the past.However,there remains no definitive evidence in the literature for or against the utilization of systemic glucocorticoids in seriously ill patients with coronavirus-related severe respiratory disease,or indeed in other types of severe respiratory disease.In this study,we hope to discover evidence either supporting or opposing the systemic therapeutic administration of glucocorticoids in patients with severe coronavirus disease 2019.

关 键 词：2019 Novel coronavirus Coronavirus disease 2019 GLUCOCORTICOIDS Severe pneumonia Acute respiratory distress syndrome 

分 类 号：R373[医药卫生—病原生物学]