Núñez-Gil Iván J, Estrada Vicente, Fernández-Pérez Cristina, Feltes Gisela, Vedia Oscar, Vergara-Uzcategui Carlos E, Moreno-Menguía Víctor H, Cerrato Enrico, D'Ascenzo Fabrizio, Raposeiras-Roubin Sergio, Martín-Sánchez F Javier, Alfonso-Rodríguez Emilio, Huang Jia, Ramakrishna Harish, Gil-Higes Emma, Fernández-Ortiz Antonio, Macaya Carlos
Hospital Clínico San Carlos, Madrid, Spain.
Fundación Instituto para la Mejora de la Asistencia Sanitaria (IMAS), Madrid, Spain.
Contemp Clin Trials Commun. 2020 Dec;20:100654. doi: 10.1016/j.conctc.2020.100654. Epub 2020 Sep 23.
The disease produced by the new coronavirus known as SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2), named COVID-19 (Coronavirus Disease-2019) has recently been classified as a pandemic by the World Health Organization (WHO). However, scarce clinical data is available and generally limited to the Chinese population due to the first cases were identified in Wuhan (Hubei, China).This article describes the rationale and design of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID 19) registry (ClinicalTrials.gov Identifier: NCT04334291). With an ambispective cohort design, eligible patients are those discharged, deceased or alive, from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion. With a current recruitment of more than 7000 cases, in 46 hospitals in 8 countries, since it is not possible to estimate the sample size based on literature reports, the investigators will try to get the maximum numbers of patients possible. The study primary objective is all cause mortality and aims to characterize the clinical profile of patients infected in order to develop a prognostic clinical score allowing, rapid logistic decision making. As secondary objectives, the analysis of other clinical events, the risk-adjusted influence of treatments and previous comorbidities of patients infected with the disease will be performed.The results of HOPE COVID-19 will contribute to a better understanding of this condition. We aim to describe the management of this condition as well as the outcomes in relation to the therapy chosen, in order to gain insight into improving patient care in the coming months.
ClinicalTrials.gov. Unique identifier: NCT04334291.
由新型冠状病毒SARS-CoV-2（严重急性呼吸综合征冠状病毒2）引起的疾病，命名为COVID-19（2019冠状病毒病），最近被世界卫生组织（WHO）列为大流行病。然而，由于首例病例在中国武汉（湖北）被发现，目前临床数据稀缺，且一般仅限于中国人群。本文描述了HOPE COVID-19（COVID-19健康结局预测评估）注册研究（ClinicalTrials.gov标识符：NCT04334291）的基本原理和设计。采用前瞻性队列设计，符合条件的患者为任何医院中心确诊或高度疑似COVID-19的出院、死亡或存活患者。由于无法根据文献报道估计样本量，目前在8个国家的46家医院招募了7000多例病例，研究人员将尽量纳入尽可能多的患者。该研究的主要目标是全因死亡率，旨在描述感染患者的临床特征，以便制定一个预后临床评分，用于快速的后勤决策。作为次要目标，将对其他临床事件、治疗的风险调整影响以及感染该疾病患者的既往合并症进行分析。HOPE COVID-19的结果将有助于更好地了解这种疾病。我们旨在描述这种疾病的管理以及与所选治疗相关的结局，以便在未来几个月深入了解改善患者护理的方法。
ClinicalTrials.gov。唯一标识符：NCT04334291。
