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临床试验/NCT04778020
NCT04778020已完成不适用

International COVID-19 Clinical Evaluation Registry -2 (HOPE-2)

St Carlos Hospital, Madrid, Spain1 个研究点 分布在 1 个国家目标入组 9,299 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9,299
试验地点
1
主要终点
DEATH

研究概览

简要总结

PURPOSE. The main objective of the present study is to carefully characterize the clinical profile of individuals with lasting sequelae after a COVID-19 admission.

As secondary objectives, the analysis of the risk-adjusted influence of COVID-19 severity, previous comorbidities and management of patients discharged after COVID-19 will be performed.

DESIGN AND STATISTICAL ANALYSIS Cross-sectional and prospective registry, a real life "all comers" type, with voluntary participation, without specific funding or conflicts of interest.

It is a study initiated by researcher that will have advanced statistical support from the IMAS foundation (Institute for the Improvement of Health Care, Madrid, Spain) and the Cardiovascular Research Foundation (FIC, Madrid, Spain).

International level.

PARTICIPANTS PROTOCOL. The study has been approved by Hospital Clinico San Carlos Ethic´s Committee (21/128-E) and the institutional board of each participating center.

The present study proposes the continuation in time of the work previously carried out in the HOPE registry.

It proposes to select all the patients attended in any health center (with in hospital beds), who have been discharged or have died up to 31st august 2020.

All will be considered eligible with a positive COVID-19 test (any type) or if their attending physicians consider them highly likely to have presented the infection.

Given the anonymous characteristics of the registry and the health alarm situation generated by the virus, in principle, it is not considered necessary to provide written informed consent.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis.

排除标准

  • There are no exclusion criteria, except for the patient's explicit refusal to participate.

结局指标

主要结局

DEATH

时间窗: through study completion, an average of 1 year

Number of participants dead by any cause during follow up.

次要结局

  • Any POSTCOVID-19 symptom(through study completion, an average of 1 year)

研究者

发起方
St Carlos Hospital, Madrid, Spain
申办方类型
Other
责任方
Principal Investigator
主要研究者

IVAN J NUÑEZ GIL

MD, PhD, MSc. Principal Investigator

St Carlos Hospital, Madrid, Spain

研究点 (1)

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