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临床试验/NCT04567576
NCT04567576Unknown不适用

Predictive Factors for COVID-19 in Rheumatology Study Based on Information Collected in The COVID-19 Global Rheumatology Alliance

Fundación Santa Fe de Bogota0 个研究点目标入组 150 人开始时间: 2020年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
150
主要终点
Clinical behavior of the disease // COVID-19

研究概览

简要总结

We seek to study the behaviour of Coronavirus infection in patients with rheumatological and/or autoimmune comorbidities, understood as a particular pathophysiological universe with its own risks and eventual benefits, until now fully hypothetical to be confirmed by means of real and recent evidence. On March 12, 2020, an initiative called the Global Alliance for COVID-19 in Rheumatology (The COVID-19 Rheumatology Alliance) arises, as a rapid response of international coordination whose ultimate goal is to serve as help or guideline for all those doctors who seek be faced with receiving, evaluating, understanding and caring for a patient with rheumatological and / or autoimmune diseases in relation to the imminent risk of COVID-19.

详细描述

Within this context, this study seeks to use the information registered by the Fundación Santa Fe de Bogotá University Hospital as a participating centre. It is intended, under a prospective cohort methodology, to identify, analyze and compare predictive factors of the clinical course of COVID-19 in patients with baseline diagnoses of rheumatological or autoimmune diseases with the intention of establishing well-founded parameters that contribute to the improvement in terms of strategies of prevention, management and prognosis; benefiting both directly treating physicians and patients, as well as indirectly a health system that is predicted to be pushed to the limit as time passes.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years.
  • Have a diagnosis of a rheumatological disease and / or an autoimmune disease by meeting its own and standardized classification criteria.
  • Confirmed diagnosis of COVID-19 by RT-PCR test
  • Being a patient at the Fundación Santa Fe de Bogotá University Hospital.
  • Be enroled in the registry of the Global Alliance for COVID-19 in Rheumatology.

排除标准

  • Loss of follow-up due to referral to an institution other than the Fundación Santa Fe de Bogotá University Hospital, before documenting the outcome of his clinical picture.

研究组 & 干预措施

Exposed

Patients with underlying rheumatological or autoimmune diseases who have a confirmed infection by 2019-nCoV (COVID-19) who at the time of diagnosis (of infection) receive pharmacological treatment with disease modifying antirheumatic drugs (DMARDs).

干预措施: Disease-modifying antirheumatic drugs (DMARDs) (Drug)

结局指标

主要结局

Clinical behavior of the disease // COVID-19

时间窗: 1-12 weeks

It will be considered as 1. Severe, if it meets at least one of the following characteristics (based on what is registered in the main center's database): * If you were hospitalized: What was the highest level of care you required during the illness? → o Required invasive mechanical ventilation or extracorporeal membrane oxygenation * If the symptoms did not resolve and the patient was hospitalized: What is the highest level of care that has been required in the course of the present illness so far? o Required mechanical ventilation or extracorporeal membrane oxygenation

Mortality

时间窗: 1-12 weeks

It will be considered as 1. Yes, if it meets at least one of the following characteristics (based on what is registered in the main center's database): • Has the patient died? o Yes, he passed away

次要结局

未报告次要终点

研究者

发起方
Fundación Santa Fe de Bogota
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Maldonado Cañón

Research Assistant

Fundación Santa Fe de Bogota

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