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临床试验/NCT05046769
NCT05046769招募中不适用

COVID-19: A Scope Research on Epidemiology and Clinical Course

Instituto de Saude Publica da Universidade do Porto1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2020年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Clinical, biological, psychosocial characteristics

研究概览

简要总结

Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV) 2 infection and the associated coronavirus disease 2019 (COVID-19) are the most recent international health threat challenging our ability to protect populations, to avoid severe outcomes and to understand both the population dynamics of this new condition and the breath of individual responses. Gathering information on the clinical course of the disease and the risk of transmission is essential to design effective therapeutic solutions and preventive measures. The aim of the study proposed, to be carried out at University Hospital Center of "São João" (CHUSJ), is to recruit and follow-up a cohort of patients diagnosed with SARS-CoV-2 infection, to evaluate the clinical course of SARS-CoV-2 infection and COVID-19 cases, to identify prognostic factors and to measure the risk of reinfection. Additionally, researchers intend to characterize the patients and household contacts to describe the dynamics of infection, to calculate household infection attack rate, and to perform the genetic sequencing of SARS-CoV-2 to understand determinants of disease course (namely long-term effects) and risk of household transmission. A sample of participants, identified during the process of evaluation of symptomatic individuals, at the same institution, and negative for SARS-CoV-2 will be selected as negative controls.

Participants will be consecutively recruited and the study is expected to enroll patients as long as the pandemic remains. Information will be gathered based on clinical individual charts, hospital data-bases (example: for administrative data) and individual computer assisted interviews to be performed at pre-defined intervals (3, 12 and 24 months) or according to clinical needs.

The project was approved by the local Ethical Committee and the Data Protection relevant authorities.

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

  • Individuals diagnosed with SARS-2-CoV-2 infection treated at CHUSJ and cohabitants able to give informed consent;
  • individuals who underwent the test for diagnosis of infection by SARS-CoV-2 at CHUSJ with negative result able to give informed consent.

排除标准

  • Inability to obtain informed consent;

结局指标

主要结局

Clinical, biological, psychosocial characteristics

时间窗: 24 months

Describe the clinical, biological and psychosocial characteristics SARS-CoV-2 infected inpatients or outpatients identified in our hospital center

次要结局

  • Prognostic factors of course of disease(24 months)
  • Reinfection rate(24 months)
  • Genome sequence of SARS-CoV-2(24 months)
  • Household contacts infection attack rate(3 months)

研究者

发起方
Instituto de Saude Publica da Universidade do Porto
申办方类型
Other
责任方
Principal Investigator
主要研究者

Margarida Fernandes Tavares

Senior researcher

Instituto de Saude Publica da Universidade do Porto

研究点 (1)

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